A Phase 3 interventional study of pregabalin and placebo in Neuropathy, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Terminated at 63 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-28.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.
Based on DMC interim efficacy analysis results indicating a low probability for success the study was terminated on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's enrollment of 377 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: pregabalin
Drug: placebo
Pregabalin 75 mg-300mg twice daily during the course of the study.
Subjects may be assigned to placebo during this study. The study duration is approximately 19 weeks.
Change From Baseline in Mean Pain Score at Endpoint (up to Week 16)
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their Human Immunodeficiency Virus (HIV) neuropathy pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method, modified Baseline Observation Carried Forward (mBOCF).
Time frame: Baseline, Endpoint (up to Week 16)
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC)
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category is reported.
Time frame: Week 16
Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC)
The CGIC scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGIC). At final visit, the participants CGIC will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse. Number of participants in each category is reported.
Time frame: Week 16
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)
Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how HIV neuropathy pain has interfered with their sleep during the past 24 hours on an 11-point NRS ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). Endpoint was the last observation for a participant assessed using specified imputation method.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)
Weekly current pain score was defined as the mean of the daily current pain diary ratings split into 7 day intervals. Participants rated current ("right now") HIV neuropathy pain an 11-point NRS ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16)
BPI-sf:5-item self-administered questionnaire to assess severity,impact of pain on daily functions. Pain Severity Index (PSI):average of Question 1-4 each measured severity of pain over past 24-hours on 11-point scale (0=no pain to 10=worst possible pain). Pain Interference Index (PII):average of 7 pain interference items of Question 5 that measured level of interference of pain on daily function on 11-point scale (0=does not interfere to 10=completely interferes). For PSI, PII range:0-10 higher score=higher pain/interference. Endpoint=last observation for participant as per imputation method.
Time frame: Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16)
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16)
NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors and 2 temporal items. Results reported for the 10 descriptors (burning, squeezing, pressure, electric shocks, stabbing, light touching of area, pressure of area, cold of area, pins and needles, tingling) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) scale. Endpoint was the last observation for a participant assessed using specified imputation method.
Time frame: Baseline, Endpoint (up to Week 16)
Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16)
NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors, and 2 temporal items. Results reported for categorical change in temporal items assessed on 5-point scale for duration of spontaneous pain (1=continuously, 2=8-12 hours \[hrs\], 3=4-7 hrs, 4=1-3 hrs, 5=less than 1 hr), numbers of pain attacks (1=more than 20, 2=11-20 attacks, 3=6-10 attacks, 4=1-5 attacks, 5=no attack). Change data categorized as worsened (negative change), unchanged (no change), and improved (positive change). Endpoint=last observation as per imputation method.
Time frame: Baseline, Endpoint (up to Week 16)
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16)
NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (subscales: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. The relevant subscales and total score were transformed to 0-1, higher score indicates a greater intensity of pain. Endpoint=last observation for participant as per imputation method.
Time frame: Baseline, Endpoint (up to Week 16)
Total Sleep Time (TST) and Minutes of Interrupted Sleep (MIS)
Total sleep time is the number of minutes asleep between time of sleep onset to morning awakening and MIS is the number of minutes spent awake after sleep onset to final awakening. TST and MIS were determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.
Time frame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
Sleep Fragmentation Index (SFI)
SFI is a measure to quantify sleep restlessness. SFI calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. SFI determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on wrist like a watch. It was programmed to record movements while device was being worn. Endpoint was the last observation for a participant assessed using imputation method.
Time frame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
Sleep Efficiency
Sleep efficiency is the time spent asleep divided by total time between sleep onset and sleep end, multiplied by 100. Sleep efficiency was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.
Time frame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
Total Activity Counts
Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the "day" (non sleep period). A total activity count was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.
Time frame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
Percentage Day Time Above Sedentary Level
Percentage of time above sedentary level is number of epochs (60 seconds) with greater than (\>) 200 activity counts per minute divided by total number of epochs during the "day" (non sleep period) multiplied by 100. This was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.
Time frame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16)
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. Endpoint was the last observation for a participant assessed using imputation method.
Time frame: Baseline, Endpoint (up to Week 16)
Medical Outcomes Study-Sleep Scale (MOS-SS): Number of Participants With Optimal Sleep
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Endpoint was the last observation for a participant assessed using imputation method.
Time frame: Baseline, Endpoint (up to Week 16)
Change From Baseline in Hospital Anxiety and Depression Scales (HADS) at Endpoint (up to Week 16)
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Endpoint was the last observation for a participant assessed using imputation method.
Time frame: Baseline, Endpoint (up to Week 16)
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16)
SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical \[R-P\], role-emotional \[R-E\]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).
Time frame: Baseline, Endpoint (up to Week 16)
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
WPAI: 6-question participant rated questionnaire to determine the degree to which specific health problem (SHP) affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Number of participants who responded "Yes/No" to Question 1: Are you currently employed (working for pay)? are reported.
Time frame: Baseline, Week 16, 17
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days. A participant who had responded 'no' to question 1 regarding employment status reported hours of work and as this was a self-reported questionnaire the source data were included.
Time frame: Baseline, Week 16, 17
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).
Time frame: Baseline, Week 16, 17
Diagnostic Neuropathy Assessment
Time frame: Screening
Number of Participants With Treatment-Emergent (TE) Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to 28 days after last dose
Number of Participants With Abnormal Laboratory Test Findings
Laboratory tests included hematology, chemistry, cluster of differentiation 4 (CD4) count and cluster of differentiation 8 (CD8) count, HIV plasma viral load, B12, Venereal Disease Research Laboratory (VDRL), toxic screens for drugs and alcohol, reflex thyroid-stimulating hormone (TSH), urinalysis. Number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time was reported.
Time frame: Screening up to Week 17
Number of Participants With Positive Serum and Urine Pregnancy
Serum pregnancy test (regardless of childbearing potential) and urine pregnancy test for all female participants were performed.
Time frame: Screening for serum pregnancy test, Week 1 for urine pregnancy test
Number of Participants With Abnormal Physical Examination Findings
A physical examination included an examination of the general appearance, skin, chest, pulses, pulmonary, cardiovascular, head, eyes, ears, nose, throat, abdominal, and extremities.
Time frame: Screening, Week 8, 17
Body Weight
Time frame: Screening, Week 1, 4, 8, 12, 16, 17
Sitting Systolic and Diastolic Blood Pressure
Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.
Time frame: Screening, Week 1, 4, 8, 12, 16, 17
Sitting Heart Rate
Time frame: Screening, Week 1, 4, 8, 12, 16, 17
Number of Participants With Neurological Examination Findings
A neurological examination consisted of examination of the mental state, cranial nerve function, motor function (reflexes of patellar, achilles, biceps, babinski and coordination) and sensory function (sharp sensation of dorsal surface of right and left great toe, light touch of lower extremities \[LE\], right and left first metatarsal joint position sense, and vibration sensation \[vibration is felt for \< 6 seconds = markedly diminished, 6 to 10 seconds = mild loss, \> 10 seconds = normal\]).
Time frame: Screening
Number of Participants Who Met Mini-International Neuropsychiatric Interview (MINI) Criteria
MINI: short structured clinical interview to make diagnoses of psychiatric disorders according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or International Classifications of Disease-10 (ICD-10). In the MINI Modules, participants were asked a series of Yes/No questions.
Time frame: Screening
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.
Time frame: Screening, Post-Baseline (Week 4 up to Week 17)
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated "Over past 2 weeks, how often bothered by any of following problems?": little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual (8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity.
Time frame: Screening
| Milestone | Pregabalin | Placebo |
|---|---|---|
| Started | 183 | 194 |
| Treated | 183 | 192 |
| Completed | 127 | 131 |
| Not completed | 56 | 63 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Lost to follow-up | 3 | 8 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: Protocol violation | 1 | 3 |
| Withdrew: Pregnancy | 1 | 0 |
| Withdrew: Study terminated by sponsor | 43 | 43 |
| Withdrew: Other | 1 | 2 |
| Withdrew: Randomized but not treated | 0 | 2 |
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their Human Immunodeficiency Virus (HIV) neuropathy pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method, modified Baseline Observation Carried Forward (mBOCF).
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline | 6.76 ± 1.194 | 6.85 ± 1.222 |
| Change at Endpoint | -2.26 ± 2.200 | -2.36 ± 2.288 |
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category is reported.
| participants | Pregabalin | Placebo |
|---|---|---|
| Very Much Improved | 42 | 51 |
| Much Improved | 69 | 66 |
| Minimally Improved | 42 | 36 |
| No Change | 13 | 17 |
| Minimally Worse | 5 | 2 |
| Much Worse | 2 | 4 |
| Very Much Worse | 0 | 0 |
The CGIC scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGIC). At final visit, the participants CGIC will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse. Number of participants in each category is reported.
| participants | Pregabalin | Placebo |
|---|---|---|
| Very Much Improved | 45 | 47 |
| Much Improved | 59 | 53 |
| Minimally Improved | 48 | 49 |
| No Change | 17 | 25 |
| Minimally Worse | 3 | 2 |
| Much Worse | 0 | 0 |
| Very Much Worse | 0 | 0 |
Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how HIV neuropathy pain has interfered with their sleep during the past 24 hours on an 11-point NRS ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). Endpoint was the last observation for a participant assessed using specified imputation method.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n=183, 191) | 6.55 ± 1.643 | 6.70 ± 1.456 |
| Change at Week 1 (n=177, 182) | -0.48 ± 1.067 | -0.37 ± 1.003 |
| Change at Week 2 (n=168, 170) | -0.85 ± 1.317 | -0.66 ± 1.292 |
| Change at Week 3 (n=163, 163) | -1.09 ± 1.505 | -0.81 ± 1.373 |
| Change at Week 4 (n=153, 160) | -1.42 ± 1.804 | -1.20 ± 1.665 |
| Change at Week 5 (n=150, 159) | -1.81 ± 1.952 | -1.49 ± 1.824 |
| Change at Week 6 (n=144, 152) | -1.95 ± 2.125 | -1.81 ± 1.903 |
| Change at Week 7 (n=145, 145) | -2.06 ± 2.234 | -1.94 ± 1.987 |
| Change at Week 8 (n=139, 145) | -2.01 ± 2.194 | -2.04 ± 2.103 |
| Change at Week 9 (n=135, 137) | -2.45 ± 2.382 | -2.32 ± 2.154 |
| Change at Week 10 (n=131, 135) | -2.48 ± 2.315 | -2.39 ± 2.175 |
| Change at Week 11 (n=125, 133) | -2.56 ± 2.393 | -2.47 ± 2.207 |
| Change at Week 12 (n=122, 131) | -2.69 ± 2.354 | -2.59 ± 2.291 |
| Change at Week 13 (n=118, 127) | -2.73 ± 2.337 | -2.82 ± 2.262 |
| Change at Week 14 (n=118, 129) | -2.81 ± 2.442 | -2.90 ± 2.346 |
| Change at Week 15 (n=117, 127) | -2.90 ± 2.438 | -2.95 ± 2.325 |
| Change at Week 16 (n=103, 121) | -3.14 ± 2.475 | -2.94 ± 2.324 |
| Change at Endpoint (n=183, 189) | -2.40 ± 2.323 | -2.43 ± 2.296 |
Weekly current pain score was defined as the mean of the daily current pain diary ratings split into 7 day intervals. Participants rated current ("right now") HIV neuropathy pain an 11-point NRS ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n=183, 192) | 6.66 ± 1.208 | 6.71 ± 1.245 |
| Change at Week 1 (n=181, 190) | -0.43 ± 1.000 | -0.34 ± 0.917 |
| Change at Week 2 (n=174, 179) | -0.79 ± 1.236 | -0.67 ± 1.282 |
| Change at Week 3 (n=170, 172) | -1.10 ± 1.440 | -0.82 ± 1.410 |
| Change at Week 4 (n=158, 169) | -1.41 ± 1.682 | -1.17 ± 1.649 |
| Change at Week 5 (n=157, 166) | -1.74 ± 1.893 | -1.48 ± 1.845 |
| Change at Week 6 (n=152, 157) | -1.87 ± 2.042 | -1.73 ± 1.965 |
| Change at Week 7 (n=153, 153) | -1.92 ± 2.074 | -1.88 ± 2.006 |
| Change at Week 8 (n=148, 153) | -2.01 ± 2.106 | -1.99 ± 2.105 |
| Change at Week 9 (n=143, 148) | -2.30 ± 2.199 | -2.21 ± 2.180 |
| Change at Week 10 (n=138, 142) | -2.38 ± 2.172 | -2.24 ± 2.225 |
| Change at Week 11 (n=132, 136) | -2.42 ± 2.250 | -2.37 ± 2.218 |
| Change at Week 12 (n=128, 135) | -2.55 ± 2.241 | -2.44 ± 2.247 |
| Change at Week 13 (n=126, 133) | -2.53 ± 2.241 | -2.60 ± 2.208 |
| Change at Week 14 (n=124, 131) | -2.66 ± 2.307 | -2.74 ± 2.303 |
| Change at Week 15 (n=120, 132) | -2.77 ± 2.283 | -2.78 ± 2.283 |
| Change at Week 16 (n=111, 128) | -2.94 ± 2.370 | -2.81 ± 2.353 |
| Change at Endpoint (n=183, 191) | -2.24 ± 2.239 | -2.29 ± 2.302 |
BPI-sf:5-item self-administered questionnaire to assess severity,impact of pain on daily functions. Pain Severity Index (PSI):average of Question 1-4 each measured severity of pain over past 24-hours on 11-point scale (0=no pain to 10=worst possible pain). Pain Interference Index (PII):average of 7 pain interference items of Question 5 that measured level of interference of pain on daily function on 11-point scale (0=does not interfere to 10=completely interferes). For PSI, PII range:0-10 higher score=higher pain/interference. Endpoint=last observation for participant as per imputation method.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline: PSI (n=182, 192) | 6.49 ± 1.175 | 6.47 ± 1.292 |
| Change at Week 4: PSI (n=158, 169) | -1.55 ± 1.725 | -1.28 ± 1.811 |
| Change at Week 8: PSI (n=146, 154) | -2.15 ± 2.142 | -2.02 ± 2.117 |
| Change at Week 12: PSI (n=126, 137) | -2.49 ± 2.311 | -2.60 ± 2.169 |
| Change at Week 16: PSI (n=166, 166) | -2.38 ± 2.335 | -2.55 ± 2.354 |
| Change at Endpoint: PSI (n=175,182) | -2.36 ± 2.291 | -2.44 ± 2.334 |
| Baseline: PII (n=182, 192) | 5.51 ± 1.963 | 5.44 ± 2.013 |
| Change at Week 4: PII (n=158, 169) | -1.43 ± 2.068 | -1.40 ± 2.358 |
| Change at Week 8: PII (n=146, 154) | -2.00 ± 2.319 | -1.97 ± 2.312 |
| Change at Week 12: PII (n=126, 137) | -2.32 ± 2.450 | -2.32 ± 2.183 |
| Change at Week 16: PII (n=166, 165) | -2.14 ± 2.434 | -2.38 ± 2.290 |
| Change at Endpoint: PII (n=175,182) | -2.12 ± 2.415 | -2.31 ± 2.306 |
NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors and 2 temporal items. Results reported for the 10 descriptors (burning, squeezing, pressure, electric shocks, stabbing, light touching of area, pressure of area, cold of area, pins and needles, tingling) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) scale. Endpoint was the last observation for a participant assessed using specified imputation method.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline: Burning (n=183, 192) | 6.1 ± 2.33 | 6.2 ± 2.52 |
| Change at Endpoint: Burning (n=173, 176) | -2.4 ± 2.91 | -2.6 ± 3.06 |
| Baseline: Squeezing (n=183, 192) | 5.3 ± 2.57 | 5.2 ± 2.98 |
| Change at Endpoint: Squeezing (n=173, 176) | -2.1 ± 3.02 | -2.1 ± 3.03 |
| Baseline: Pressure (n=183, 192) | 5.8 ± 2.50 | 5.5 ± 2.73 |
| Change at Endpoint: Pressure (n=172, 176) | -2.3 ± 3.19 | -2.2 ± 3.15 |
| Baseline: Electric Shocks (n=183, 192) | 5.4 ± 2.76 | 5.1 ± 2.84 |
| Change at Endpoint: Electric Shocks (n=173, 176) | -2.2 ± 3.18 | -2.0 ± 3.10 |
| Baseline: Stabbing (n=183, 192) | 5.8 ± 2.46 | 6.1 ± 2.58 |
| Change at Endpoint: Stabbing (n=173, 176) | -2.2 ± 3.00 | -2.5 ± 3.11 |
| Baseline: Light Touching (n=183, 192) | 5.0 ± 2.60 | 5.0 ± 2.62 |
| Change at Endpoint: Light Touching (n=173, 176) | -1.9 ± 2.91 | -1.9 ± 3.05 |
| Baseline: Pressure of Area (n=183, 192) | 6.0 ± 2.12 | 6.0 ± 2.25 |
| Change at Endpoint: Pressure of Area (n=173, 176) | -2.5 ± 2.75 | -2.3 ± 2.99 |
| Baseline: Cold of Area (n=183, 192) | 5.9 ± 2.56 | 5.5 ± 2.87 |
| Change at Endpoint: Cold of Area (n=173, 176) | -2.2 ± 2.98 | -2.0 ± 3.07 |
| Baseline: Pins and Needles (n=183, 192) | 6.7 ± 2.14 | 6.6 ± 2.23 |
| Change at Endpoint: Pins and Needles (n=173, 176) | -2.6 ± 2.90 | -2.6 ± 3.12 |
| Baseline: Tingling (n=183, 192) | 5.8 ± 2.49 | 6.1 ± 2.42 |
| Change at Endpoint: Tingling (n=173, 176) | -2.1 ± 3.01 | -2.4 ± 3.09 |
NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors, and 2 temporal items. Results reported for categorical change in temporal items assessed on 5-point scale for duration of spontaneous pain (1=continuously, 2=8-12 hours \[hrs\], 3=4-7 hrs, 4=1-3 hrs, 5=less than 1 hr), numbers of pain attacks (1=more than 20, 2=11-20 attacks, 3=6-10 attacks, 4=1-5 attacks, 5=no attack). Change data categorized as worsened (negative change), unchanged (no change), and improved (positive change). Endpoint=last observation as per imputation method.
| participants | Pregabalin | Placebo |
|---|---|---|
| Duration of Spontaneous Pain, Worsened (n=173,172) | 31 | 33 |
| Duration of Spontaneous Pain, Unchanged(n=173,172) | 56 | 50 |
| Duration of Spontaneous Pain, Improved (n=173,172) | 86 | 89 |
| Number of Pain Attacks, Worsened (n=173, 176) | 40 | 25 |
| Number of Pain Attacks, Unchanged (n=173, 176) | 49 | 54 |
| Number of Pain Attacks, Improved (n=173, 176) | 84 | 97 |
NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (subscales: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. The relevant subscales and total score were transformed to 0-1, higher score indicates a greater intensity of pain. Endpoint=last observation for participant as per imputation method.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline: Burning Pain (n=183, 192) | 0.61 ± 0.233 | 0.62 ± 0.252 |
| Change at Endpoint: Burning Pain (n=173, 176) | -0.24 ± 0.291 | -0.26 ± 0.306 |
| Baseline: Pressing Pain (n=182, 192) | 0.55 ± 0.227 | 0.54 ± 0.248 |
| Change at Endpoint: Pressing Pain (n=173, 176) | -0.22 ± 0.280 | -0.21 ± 0.279 |
| Baseline: Paroxysmal Pain (n=183, 192) | 0.56 ± 0.227 | 0.56 ± 0.236 |
| Change at Endpoint: Paroxysmal Pain (n=173, 176) | -0.22 ± 0.272 | -0.23 ± 0.279 |
| Baseline: Evoked Pain (n=183, 192) | 0.57 ± 0.202 | 0.55 ± 0.206 |
| Change at Endpoint: Evoked Pain (n=173, 176) | -0.22 ± 0.243 | -0.21 ± 0.253 |
| Baseline: P/D (n=183, 192) | 0.62 ± 0.211 | 0.63 ± 0.199 |
| Change at Endpoint: P/D (n=173, 176) | -0.23 ± 0.282 | -0.25 ± 0.277 |
| Baseline: Total Score (n=182, 192) | 0.58 ± 0.173 | 0.57 ± 0.175 |
| Change at Endpoint: Total Score (n=173,176) | -0.22 ± 0.231 | -0.23 ± 0.236 |
Total sleep time is the number of minutes asleep between time of sleep onset to morning awakening and MIS is the number of minutes spent awake after sleep onset to final awakening. TST and MIS were determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.
| minutes | Pregabalin | Placebo |
|---|---|---|
| Endpoint: TST | 396.84 ± 5.04 | 400.29 ± 5.29 |
| Endpoint: MIS | 41.48 ± 1.45 | 45.14 ± 1.50 |
SFI is a measure to quantify sleep restlessness. SFI calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. SFI determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on wrist like a watch. It was programmed to record movements while device was being worn. Endpoint was the last observation for a participant assessed using imputation method.
| percentage of immobile bouts | Pregabalin | Placebo |
|---|---|---|
| Sleep Fragmentation Index (SFI) | 18.57 ± 0.47 | 19.60 ± 0.49 |
Sleep efficiency is the time spent asleep divided by total time between sleep onset and sleep end, multiplied by 100. Sleep efficiency was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.
| Percent time between sleep onset and end | Pregabalin | Placebo |
|---|---|---|
| Sleep Efficiency | 85.80 ± 0.39 | 84.84 ± 0.41 |
Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the "day" (non sleep period). A total activity count was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.
| activity counts per day | Pregabalin | Placebo |
|---|---|---|
| Total Activity Counts | 297350 ± 5280.2 | 305787 ± 5480.9 |
Percentage of time above sedentary level is number of epochs (60 seconds) with greater than (\>) 200 activity counts per minute divided by total number of epochs during the "day" (non sleep period) multiplied by 100. This was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.
| percentage of day time | Pregabalin | Placebo |
|---|---|---|
| Percentage Day Time Above Sedentary Level | 52.43 ± 0.51 | 52.28 ± 0.53 |
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. Endpoint was the last observation for a participant assessed using imputation method.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline: Sleep Disturbance (n=183, 192) | 35.27 ± 22.127 | 39.32 ± 22.800 |
| Change at Endpoint: Sleep Disturbance (n=173, 175) | -6.58 ± 22.856 | -8.64 ± 25.317 |
| Baseline: Snoring (n=181, 192) | 25.30 ± 31.456 | 26.04 ± 34.077 |
| Change at Endpoint: Snoring (n=171, 175) | 0.94 ± 35.301 | -3.77 ± 33.862 |
| Baseline: SOB (n= 183, 192) | 22.08 ± 27.216 | 25.83 ± 28.567 |
| Change at Endpoint: SOB (n=173, 175) | -3.01 ± 28.938 | -7.09 ± 30.552 |
| Baseline: Quantity (n= 183, 192) | 7.50 ± 1.969 | 7.96 ± 3.976 |
| Change at Endpoint: Quantity (n=173, 175) | 0.27 ± 1.814 | 0.36 ± 2.082 |
| Baseline: Adequacy (n= 183, 192) | 57.81 ± 25.776 | 54.22 ± 24.801 |
| Change at Endpoint: Adequacy (n=173, 175) | 5.26 ± 30.319 | 4.63 ± 30.091 |
| Baseline: Somnolence (n= 183, 192) | 26.05 ± 21.078 | 29.10 ± 20.773 |
| Change at Endpoint: Somnolence (n=173, 175) | -0.77 ± 22.946 | -4.23 ± 24.136 |
| Baseline: Sleep Problems Index (n= 183, 192) | 32.97 ± 16.726 | 36.91 ± 16.862 |
| Change at Endpoint:Sleep Problems Index(n=173,175) | -4.25 ± 17.382 | -6.70 ± 18.358 |
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Endpoint was the last observation for a participant assessed using imputation method.
| participants | Pregabalin | Placebo |
|---|---|---|
| Baseline (n=183, 192) | 80 | 77 |
| Endpoint (n=173, 176) | 80 | 80 |
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Endpoint was the last observation for a participant assessed using imputation method.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline: HADS-A (n=183, 192) | 5.99 ± 4.065 | 6.32 ± 4.216 |
| Change at Endpoint: HADS-A (n=173, 176) | -1.03 ± 4.550 | -1.50 ± 4.593 |
| Baseline: HADS-D (n=183, 192) | 4.92 ± 3.478 | 5.42 ± 3.885 |
| Change at Endpoint: HADS-D (n=173, 176) | 0.07 ± 4.238 | -1.02 ± 4.038 |
SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical \[R-P\], role-emotional \[R-E\]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline: Ph Fn (n=183, 192) | 55.25 ± 24.913 | 56.30 ± 24.444 |
| Change at Endpoint: Ph Fn (n=173, 176) | 8.29 ± 26.438 | 6.85 ± 27.839 |
| Baseline: R-P (n=183, 192) | 55.43 ± 25.806 | 58.37 ± 25.078 |
| Change at Endpoint: R-P (n=173, 176) | 9.03 ± 27.012 | 7.05 ± 29.122 |
| Baseline: BP (n=183, 192) | 48.11 ± 20.149 | 48.47 ± 21.855 |
| Change at Endpoint: BP (n=172, 176) | 13.13 ± 24.846 | 12.86 ± 28.888 |
| Baseline: GH (n=183, 192) | 58.83 ± 20.583 | 59.47 ± 19.808 |
| Change at Endpoint: GH (n=173, 176) | 8.25 ± 20.985 | 7.37 ± 21.300 |
| Baseline: Ph C (n=183, 192) | 39.66 ± 8.632 | 40.06 ± 8.110 |
| Change at Endpoint: Ph C (n=171, 176) | 4.44 ± 8.530 | 4.17 ± 9.528 |
| Baseline: Vit (n=183, 192) | 61.01 ± 16.338 | 59.80 ± 18.443 |
| Change at Endpoint: Vit (n=172, 176) | 2.86 ± 19.196 | 4.87 ± 21.014 |
| Baseline: So Fn (n=183, 192) | 68.37 ± 22.498 | 66.34 ± 22.825 |
| Change at Endpoint: So Fn (n=173, 176) | 2.60 ± 26.866 | 6.18 ± 23.299 |
| Baseline: R-E (n=183, 192) | 63.80 ± 26.333 | 67.93 ± 25.214 |
| Change at Endpoint: R-E (n=173, 176) | 6.74 ± 29.536 | 1.85 ± 29.307 |
| Baseline: MnH (n=183, 192) | 69.07 ± 16.902 | 68.59 ± 19.133 |
| Change at Endpoint: MnH (n=172, 176) | 3.11 ± 20.698 | 4.12 ± 19.776 |
| Baseline: Mn C (n=183, 192) | 47.12 ± 10.037 | 47.18 ± 10.473 |
| Change at Endpoint: Mn C (n=171, 176) | 1.18 ± 11.394 | 1.21 ± 10.519 |
WPAI: 6-question participant rated questionnaire to determine the degree to which specific health problem (SHP) affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Number of participants who responded "Yes/No" to Question 1: Are you currently employed (working for pay)? are reported.
| participants | Pregabalin | Placebo |
|---|---|---|
| Baseline: Employed (n=183, 192) | 57 | 57 |
| Week 16: Employed (n=169, 170) | 57 | 51 |
| Week 17: Employed (n=167, 171) | 58 | 47 |
| Baseline: Unemployed (n=183, 192) | 126 | 135 |
| Week 16: Unemployed (n=169, 170) | 112 | 119 |
| Week 17: Unemployed (n=167, 171) | 109 | 124 |
WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days. A participant who had responded 'no' to question 1 regarding employment status reported hours of work and as this was a self-reported questionnaire the source data were included.
| hours | Pregabalin | Placebo |
|---|---|---|
| Baseline, Hours Missed,Leg/Foot Pain (n=57, 58) | 5.58 ± 10.601 | 4.86 ± 11.488 |
| Week 16, Hours Missed,Leg/Foot Pain (n=57, 54) | 2.05 ± 5.044 | 2.41 ± 6.603 |
| Week 17, Hours Missed,Leg/Foot Pain (n=58, 48) | 3.03 ± 5.364 | 1.27 ± 2.703 |
| Baseline, Hours Missed,Other Reason (n=57, 58) | 12.77 ± 21.253 | 7.31 ± 15.144 |
| Week 16, Hours Missed,Other Reason (n=57, 54) | 7.53 ± 15.121 | 6.74 ± 14.070 |
| Week 17, Hours Missed,Other Reason (n=58, 48) | 7.72 ± 17.887 | 2.94 ± 6.635 |
| Baseline: Hours Worked (n=57, 58) | 32.54 ± 17.367 | 28.76 ± 18.780 |
| Week 16: Hours Worked (n=57, 54) | 37.44 ± 19.441 | 32.72 ± 19.835 |
| Week 17: Hours Worked (n=58, 48) | 34.83 ± 20.670 | 38.15 ± 21.399 |
WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline: Productivity Affected (n=55, 57) | 5.00 ± 2.480 | 5.93 ± 2.513 |
| Week 16: Productivity Affected (n=60, 54) | 3.60 ± 2.402 | 3.15 ± 2.771 |
| Week 17: Productivity Affected (n=58, 48) | 3.40 ± 2.615 | 3.00 ± 2.806 |
| Baseline: Daily Activity Affected (n=183, 192) | 6.03 ± 2.078 | 6.12 ± 2.190 |
| Week 16: Daily Activity Affected (n=169, 170) | 3.75 ± 2.547 | 3.66 ± 2.769 |
| Week 17: Daily Activity Affected (n=167, 171) | 3.82 ± 2.568 | 3.64 ± 2.754 |
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
| participants | Pregabalin | Placebo |
|---|---|---|
| AEs | 126 | 117 |
| SAEs | 7 | 7 |
Laboratory tests included hematology, chemistry, cluster of differentiation 4 (CD4) count and cluster of differentiation 8 (CD8) count, HIV plasma viral load, B12, Venereal Disease Research Laboratory (VDRL), toxic screens for drugs and alcohol, reflex thyroid-stimulating hormone (TSH), urinalysis. Number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time was reported.
| participants | Pregabalin | Placebo |
|---|---|---|
| Number of Participants With Abnormal Laboratory Test Findings | 165 | 170 |
Serum pregnancy test (regardless of childbearing potential) and urine pregnancy test for all female participants were performed.
No measurements were reported for this outcome.
A physical examination included an examination of the general appearance, skin, chest, pulses, pulmonary, cardiovascular, head, eyes, ears, nose, throat, abdominal, and extremities.
| participants | Pregabalin | Placebo |
|---|---|---|
| Screening: General (n=183, 192) | 16 | 13 |
| Week 8: General (n=146, 154) | 12 | 7 |
| Week 17: General (n=170, 174) | 11 | 6 |
| Screening: Skin (n=183, 192) | 30 | 37 |
| Week 8: Skin (n=146, 154) | 20 | 20 |
| Week 17: Skin (n=170, 174) | 21 | 32 |
| Screening: Chest (n=183, 192) | 6 | 4 |
| Week 8: Chest (n=146, 154) | 2 | 3 |
| Week 17: Chest (n=170, 174) | 4 | 2 |
| Screening: Pulses (n=183, 191) | 3 | 1 |
| Week 8: Pulses (n=146, 153) | 2 | 1 |
| Week 17: Pulses (n=170, 174) | 1 | 2 |
| Screening: Lungs (n=183, 192) | 2 | 6 |
| Week 8: Lungs (n=146, 154) | 2 | 3 |
| Week 17: Lungs (n=170, 174) | 3 | 5 |
| Screening: Heart (n=183, 192) | 3 | 4 |
| Week 8: Heart (n=146, 154) | 4 | 3 |
| Week 17: Heart (n=170, 174) | 4 | 3 |
| Screening: Abdomen (n=183, 192) | 11 | 6 |
| Week 8: Abdomen (n=146, 154) | 9 | 2 |
| Week 17: Abdomen (n=170, 174) | 8 | 6 |
| Screening: Extremities (n=183, 192) | 50 | 46 |
| Week 8: Extremities (n=146, 154) | 28 | 26 |
| Week 17: Extremities (n=170, 174) | 29 | 23 |
| Screening: Head (n=183, 192) | 2 | 5 |
| Week 8: Head (n=146, 154) | 0 | 2 |
| Week 17: Head (n=170, 174) | 2 | 2 |
| Screening: Ears (n=181, 191) | 1 | 3 |
| Week 8: Ears (n=145, 154) | 0 | 0 |
| Week 17: Ears (n=170, 174) | 1 | 3 |
| Screening: Eyes (n=183, 192) | 12 | 7 |
| Week 8: Eyes (n=146, 154) | 8 | 5 |
| Week 17: Eyes (n=170, 174) | 9 | 6 |
| Screening: Nose (n=183, 192) | 0 | 3 |
| Week 8: Nose (n=146, 154) | 3 | 4 |
| Week 17: Nose (n=170, 174) | 3 | 1 |
| Screening: Throat (n=183, 192) | 3 | 3 |
| Week 8: Throat (n=146, 154) | 4 | 6 |
| Week 17: Throat (n=170, 174) | 5 | 2 |
| kilogram | Pregabalin | Placebo |
|---|---|---|
| Screening (n=183, 192) | 70.8 ± 17.7 | 72.0 ± 17.3 |
| Week 1 (n=183, 192) | 71.2 ± 17.76 | 72.5 ± 17.84 |
| Week 4 (n=158, 169) | 72.6 ± 19.02 | 71.8 ± 16.88 |
| Week 8 (n=146, 154) | 73.1 ± 19.35 | 72.1 ± 17.17 |
| Week 12 (n=127, 137) | 74.0 ± 19.01 | 72.7 ± 17.20 |
| Week 16 (n=170, 176) | 73.6 ± 18.06 | 72.5 ± 17.00 |
| Week 17 (n=167, 171) | 73.6 ± 18.13 | 72.6 ± 16.95 |
Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.
| millimeter of mercury (mmHg) | Pregabalin | Placebo |
|---|---|---|
| Screening: SBP (n=183, 192) | 121.2 ± 16.18 | 122.1 ± 15.02 |
| Week 1: SBP (n=183, 192) | 119.9 ± 14.58 | 120.4 ± 14.79 |
| Week 4: SBP (n=159, 169) | 117.9 ± 16.42 | 119.8 ± 15.07 |
| Week 8: SBP (n=147, 154) | 118.6 ± 14.24 | 120.7 ± 15.18 |
| Week 12: SBP (n=127, 137) | 120.2 ± 15.33 | 121.7 ± 14.30 |
| Week 16: SBP (n=171, 176) | 119.3 ± 15.71 | 122.9 ± 13.67 |
| Week 17: SBP (n=167, 171) | 120.1 ± 15.89 | 121.6 ± 14.35 |
| Screening: DBP (n=183, 192) | 78.7 ± 11.08 | 78.4 ± 10.84 |
| Week 1: DBP (n=183, 192) | 76.9 ± 10.48 | 77.5 ± 10.40 |
| Week 4: DBP (n=159, 169) | 76.0 ± 12.01 | 76.5 ± 10.43 |
| Week 8: DBP (n=147, 154) | 76.0 ± 11.25 | 77.6 ± 11.27 |
| Week 12: DBP (n=127, 137) | 77.5 ± 10.62 | 78.0 ± 10.07 |
| Week 16: DBP (n=171, 176) | 76.4 ± 11.07 | 78.1 ± 9.52 |
| Week 17: DBP (n=167, 171) | 76.4 ± 11.28 | 78.5 ± 11.48 |
| beats per minute (bpm) | Pregabalin | Placebo |
|---|---|---|
| Screening (n=183, 192) | 75.2 ± 12.44 | 74.6 ± 11.10 |
| Week 1 (n=183, 192) | 76.0 ± 11.46 | 74.9 ± 9.27 |
| Week 4 (n=159, 169) | 77.5 ± 10.75 | 77.2 ± 10.63 |
| Week 8 (n=147, 154) | 77.4 ± 10.52 | 77.1 ± 10.32 |
| Week 12 (n=127, 137) | 78.0 ± 11.09 | 77.5 ± 11.09 |
| Week 16 (n=171, 176) | 76.2 ± 11.03 | 76.5 ± 11.17 |
| Week 17 (n=167, 171) | 76.0 ± 10.91 | 76.2 ± 10.35 |
A neurological examination consisted of examination of the mental state, cranial nerve function, motor function (reflexes of patellar, achilles, biceps, babinski and coordination) and sensory function (sharp sensation of dorsal surface of right and left great toe, light touch of lower extremities \[LE\], right and left first metatarsal joint position sense, and vibration sensation \[vibration is felt for \< 6 seconds = markedly diminished, 6 to 10 seconds = mild loss, \> 10 seconds = normal\]).
| participants | Pregabalin | Placebo |
|---|---|---|
| Cranial Nerve Function: Missing | 1 | 0 |
| Cranial Nerve Function: Normal | 178 | 192 |
| Cranial Nerve Function: Abnormal | 4 | 0 |
| Cranial Nerve Function: Not Done | 0 | 0 |
| Coordination, Gait: Missing | 1 | 1 |
| Coordination, Gait: Normal | 169 | 181 |
| Coordination, Gait: Not Evaluable | 2 | 2 |
| Coordination, Gait: Mild Ataxia | 7 | 7 |
| Coordination, Gait: Moderate Ataxia | 3 | 1 |
| Coordination, Gait: Severe Ataxia | 1 | 0 |
| Coordination, Romberg Test: Missing | 1 | 0 |
| Coordination, Romberg Test: Normal | 174 | 188 |
| Coordination, Romberg Test: Abnormal | 6 | 2 |
| Coordination, Romberg Test: Not Done | 2 | 2 |
| Reflexes, Left Patellar: Missing | 1 | 0 |
| Reflexes, Left Patellar: None/Absent | 7 | 13 |
| Reflexes, Left Patellar: Normal | 124 | 130 |
| Reflexes, Left Patellar: Not Done | 0 | 0 |
| Reflexes, Left Patellar: Hypoactive (Diminished) | 43 | 41 |
| Reflexes, Left Patellar: Hyperactive (More Brisk) | 8 | 8 |
| Reflexes, Left Patellar: Clonus (Very Intense) | 0 | 0 |
| Reflexes, Right Patellar: Missing | 1 | 0 |
| Reflexes, Right Patellar: None/Absent | 8 | 13 |
| Reflexes, Right Patellar: Normal | 124 | 129 |
| Reflexes, Right Patellar: Not Done | 1 | 0 |
| Reflexes, Right Patellar: Hypoactive (Diminished) | 42 | 41 |
| Reflexes, Right Patellar: Hyperactive (More Brisk) | 7 | 9 |
| Reflexes, Right Patellar: Clonus (Very Intense) | 0 | 0 |
| Reflexes, Left Achilles: Missing | 1 | 0 |
| Reflexes, Left Achilles: None/Absent | 92 | 100 |
| Reflexes, Left Achilles: Normal | 14 | 13 |
| Reflexes, Left Achilles: Not Done | 0 | 0 |
| Reflexes, Left Achilles: Hypoactive (Diminished) | 73 | 78 |
| Reflexes, Left Achilles: Hyperactive (More Brisk) | 3 | 1 |
| Reflexes, Left Achilles: Clonus (Very Intense) | 0 | 0 |
| Reflexes, Right Achilles: Missing | 1 | 0 |
| Reflexes, Right Achilles: None/Absent | 90 | 100 |
| Reflexes, Right Achilles: Normal | 14 | 9 |
| Reflexes, Right Achilles: Not Done | 0 | 0 |
| Reflexes, Right Achilles: Hypoactive (Diminished) | 75 | 82 |
| Reflexes, Right Achilles: Hyperactive (More Brisk) | 3 | 1 |
| Reflexes, Right Achilles: Clonus (Very Intense) | 0 | 0 |
| Reflexes, Right Biceps: Missing | 1 | 0 |
| Reflexes, Right Biceps: None/Absent | 1 | 2 |
| Reflexes, Right Biceps: Normal | 166 | 178 |
| Reflexes, Right Biceps: Not Done | 3 | 2 |
| Reflexes, Right Biceps: Hypoactive (Diminished) | 8 | 7 |
| Reflexes, Right Biceps: Hyperactive (More Brisk) | 4 | 3 |
| Reflexes, Right Biceps: Clonus (Very Intense) | 0 | 0 |
| Reflexes, Left Biceps: Missing | 1 | 0 |
| Reflexes, Left Biceps: None/Absent | 1 | 2 |
| Reflexes, Left Biceps: Normal | 169 | 180 |
| Reflexes, Left Biceps: Not Done | 2 | 1 |
| Reflexes, Left Biceps: Hypoactive (Diminished) | 7 | 6 |
| Reflexes, Left Biceps: Hyperactive (More Brisk) | 3 | 3 |
| Reflexes, Left Biceps: Clonus (Very Intense) | 0 | 0 |
| Mental State: Missing | 3 | 0 |
| Mental State: Normal | 179 | 192 |
| Mental State: Abnormal | 1 | 0 |
| Mental State: Not Done | 0 | 0 |
| Sensory Function, Right Great Toe: Missing | 1 | 0 |
| Sensory Function, Right Great Toe: Absent | 63 | 57 |
| Sensory Function, Right Great Toe: Diminished | 99 | 114 |
| Sensory Function, Right Great Toe: Normal | 5 | 7 |
| Sensory Function, Right Great Toe: Increased | 15 | 14 |
| Sensory Function, Left Great Toe: Missing | 1 | 0 |
| Sensory Function, Left Great Toe: Absent | 61 | 58 |
| Sensory Function, Left Great Toe: Diminished | 102 | 112 |
| Sensory Function, Left Great Toe: Normal | 5 | 8 |
| Sensory Function, Left Great Toe: Increased | 14 | 14 |
| Sensory Function-Light Touch, LE: Missing | 2 | 3 |
| Sensory Function-Light Touch, LE: Not Done | 7 | 6 |
| Sensory Function-Light Touch, LE: Unable to Detect | 39 | 48 |
| Sensory Function-Light Touch, LE: Hyposensitivity | 99 | 102 |
| Sensory Function-Light Touch, LE: Normal Sensation | 28 | 25 |
| Sensory Function-Light Touch, LE: Hypersensitivity | 8 | 8 |
| Sensory Function, Right Metatarsal Sense: Missing | 1 | 0 |
| Sensory Function, Right Metatarsal Sense: Normal | 129 | 143 |
| Sensory Function, Right Metatarsal Sense: Abnormal | 52 | 47 |
| Sensory Function, Right Metatarsal Sense: Not Done | 1 | 2 |
| Sensory Function, Left Metatarsal Sense: Missing | 1 | 0 |
| Sensory Function, Left Metatarsal Sense: Normal | 129 | 143 |
| Sensory Function, Left Metatarsal Sense: Abnormal | 51 | 46 |
| Sensory Function, Left Metatarsal Sense: Not Done | 2 | 3 |
| Vibration Sensation: Missing | 2 | 2 |
| Vibration Sensation: Not Done | 1 | 1 |
| Vibration Sensation: Absent | 27 | 24 |
| Vibration Sensation: Markedly Diminished | 42 | 52 |
| Vibration Sensation: Mild Loss | 86 | 79 |
| Vibration Sensation: Normal | 25 | 34 |
| Reflexes, Right Babinski: Missing | 1 | 0 |
| Reflexes, Right Babinski: Not Evaluable | 3 | 6 |
| Reflexes, Right Babinski: Absent | 173 | 180 |
| Reflexes, Right Babinski: Present | 6 | 6 |
| Reflexes, Left Babinski: Missing | 1 | 0 |
| Reflexes, Left Babinski: Not Evaluable | 3 | 6 |
| Reflexes, Left Babinski: Absent | 173 | 180 |
| Reflexes, Left Babinski: Present | 6 | 6 |
MINI: short structured clinical interview to make diagnoses of psychiatric disorders according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or International Classifications of Disease-10 (ICD-10). In the MINI Modules, participants were asked a series of Yes/No questions.
No measurements were reported for this outcome.
S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.
| participants | Pregabalin | Placebo |
|---|---|---|
| Screening: Su Attempt (n=183, 192) | 5 | 8 |
| Screening: Preparatory Acts (n=183, 192) | 5 | 8 |
| Screening: Su ID (n=183, 192) | 28 | 37 |
| Screening: SI BHV, no Su intent (n=183, 192) | 4 | 4 |
| Post-Baseline: Completed Suicide (n=178, 185) | 0 | 0 |
| Post-Baseline: Su Attempt (n=178, 185) | 0 | 1 |
| Post-Baseline: Preparatory Acts (n=178, 185) | 0 | 2 |
| Post-Baseline: Su ID (n=178, 185) | 5 | 11 |
| Post-Baseline: SI BHV, no Su intent (n=178, 185) | 0 | 0 |
PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated "Over past 2 weeks, how often bothered by any of following problems?": little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual (8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity.
| participants | Pregabalin | Placebo |
|---|---|---|
| Little Interest: Not at All (n=183, 192) | 77 | 89 |
| Little Interest: Several Days (n=183, 192) | 63 | 72 |
| Little Interest: > 1/2 Days (n=183,192) | 23 | 20 |
| Little Interest: Nearly Every Day (n=183, 192) | 20 | 11 |
| Feeling Down: Not at All (n=183, 192) | 105 | 109 |
| Feeling Down: Several Days (n=183, 192) | 61 | 59 |
| Feeling Down: > 1/2 Days the Days (n=183, 192) | 13 | 12 |
| Feeling Down: Nearly Every Day (n=183, 192) | 4 | 12 |
| Trouble With Sleep: Not at All (n=182, 192) | 63 | 68 |
| Trouble With Sleep: Several Days (n=182, 192) | 69 | 86 |
| Trouble With Sleep: > 1/2 Days (n=182, 192) | 26 | 22 |
| Trouble With Sleep: Nearly Every Day (n=182, 192) | 24 | 16 |
| Feeling Tired: Not at All (n=183, 192) | 57 | 56 |
| Feeling Tired: Several Days (n=183, 192) | 87 | 100 |
| Feeling Tired: > 1/2 Days (n=183, 192) | 27 | 29 |
| Feeling Tired: Nearly Every Day (n=183, 192) | 12 | 7 |
| Poor Appetite/Overeat: Not at All (n=183, 192) | 99 | 116 |
| Poor Appetite/Overeat: Several Days (n=183, 192) | 53 | 56 |
| Poor Appetite/Overeat: > 1/2 Days (n=183, 192) | 21 | 15 |
| Poor Appetite/Overeat: Nearly Everyday (n=183,192) | 10 | 5 |
| Feeling Bad About Self: Not at All (n=183, 192) | 124 | 138 |
| Feeling Bad About Self: Several Days (n=183, 192) | 41 | 43 |
| Feeling Bad About Self: > 1/2 Days (n=183, 192) | 12 | 6 |
| Feeling Bad About Self: Nearly Everyday(n=183,192) | 6 | 5 |
| Trouble Concentrating: Not at All (n=183, 192) | 131 | 140 |
| Trouble Concentrating: Several Days (n=183, 192) | 35 | 33 |
| Trouble Concentrating: > 1/2 Days (n=183, 192) | 11 | 13 |
| Trouble Concentrating: Nearly Everyday (n=183,192) | 6 | 6 |
| Move-Speak Slow/Fidgety: Not at All (n=183,192) | 144 | 143 |
| Move-Speak Slow/Fidgety:Several Days(n=183,192) | 23 | 33 |
| Move-Speak Slow/Fidgety: >1/2 Days (n=183, 192) | 10 | 10 |
| Move-Speak Slow/Fidgety:Nearly Everyday(n=183,192) | 6 | 6 |
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregabalin | — | 7/183 (3.8%) | 64/183 (35%) |
| Placebo | — | 7/192 (3.6%) | 47/192 (24.5%) |
| Event | Pregabalin | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/183 | 1/192 |
| Perineal abscessInfections and infestations | 1/183 | 0/192 |
| PneumoniaInfections and infestations | 1/183 | 1/192 |
| Demyelinating polyneuropathyNervous system disorders | 1/183 | 0/192 |
| Loss of consciousnessNervous system disorders | 1/183 | 0/192 |
| Peripheral sensorimotor neuropathyNervous system disorders | 1/183 | 0/192 |
| DepressionPsychiatric disorders | 1/183 | 0/192 |
| Renal failure acuteRenal and urinary disorders | 1/183 | 0/192 |
| Gallbladder disorderHepatobiliary disorders | 0/183 | 1/192 |
| Pneumocystis jiroveci pneumoniaInfections and infestations | 0/183 | 1/192 |
| Event | Pregabalin | Placebo |
|---|---|---|
| DizzinessNervous system disorders | 25/183 | 10/192 |
| HeadacheNervous system disorders | 25/183 | 26/192 |
| InfluenzaInfections and infestations | 17/183 | 12/192 |
| SomnolenceNervous system disorders | 13/183 | 4/192 |
| Age, Continuous(years) | Pregabalin | Placebo | Total |
|---|---|---|---|
| Mean | 41.2 ± 9.0 | 42.3 ± 8.4 | 41.7 ± 8.7 |
| Sex: Female, Male(Participants) | Pregabalin | Placebo | Total |
|---|---|---|---|
| Female | 121 | 116 | 237 |
| Male | 62 | 76 | 138 |
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Peripheral Nervous System Diseases→
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