A Phase 3 interventional study of placebo and pregabalin in Neuralgia and Spinal Cord Injuries, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 67 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-25.
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 if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 220 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries 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: placebo
flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period
Drug: pregabalin
Placebo
Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day)
Also known as: Lyrica
Duration Adjusted Average Change (DAAC) of Mean Pain Score
DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant.
Time frame: Baseline, Week 16
Change From Baseline in Weekly Mean Pain Score
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 16
Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 16
Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)
The PGIC is a participant-rated instrument measuring change in the participant's overall status on a 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
Time frame: Baseline, Week 16
Change From Baseline in Weekly Mean Sleep Interference Score
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]).
Time frame: Baseline, Week 16
Change From Baseline in Weekly Mean Pain Score by Week
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 1 through16
Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 16
Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score
The Modified Brief Pain Inventory (mBPI-10) Interference Scale is a self administered questionnaire that assessed pain interference with functional activities over the past week. The items were measured on an 11 point scale, ranging from "does not interfere" (0) to "completely interferes" (10). A composite score, the pain interference index, was calculated by averaging the 10 items that comprised the scale.
Time frame: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia
Participant rated pain scale. The pain produced by the applied stimulus (static mechanical allodynia - gentle constant mechanical pressure) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time frame: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia
Participant rated pain scale. The pain produced by the applied stimulus (dynamic mechanical allodynia - gentle stroking with foam brush) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time frame: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia
Participant rated pain scale. The pain produced by the applied stimulus (Punctata hyperalgesia - pinprick) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time frame: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli
Participant rated pain scale. The pain produced by the applied stimulus (Temporal summation to tactile stimuli - repeated touching/tapping) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time frame: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia
Participant rated pain scale. The pain produced by the applied stimulus (Cold allodynia - touch with cool metal rod 13-17 degrees celsius was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time frame: Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales
Participant rated pain scale. The pain produced by the applied stimulus (Cold hyperalgesia - touch with cold metal rod 4 degrees celsius) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time frame: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time frame: Baseline, Week 16
Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)
NPSI - Temporal item which assesses the duration (number of hours during the last 24 hours) of spontaneous ongoing pain. Improved duration would be a decrease in the number of hours of spontaneous ongoing pain during the last 24 hours compared to baseline.
Time frame: Baseline, Week 16
Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)
NPSI - Temporal item which assesses the paroxysmal pain (number of pain attacks during the last 24 hours). Improvement in the number of attacks would be a decrease in the number of paroxysms during the last 24 hours compared to baseline.
Time frame: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time frame: Baseline, Week 16
Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety
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.
Time frame: Baseline, Week 16
Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression
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.
Time frame: Baseline, Week 16
Change From Baseline in Weekly Mean Sleep Interference Score by Week
Pain related sleep interference was assessed on an 11 point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]).
Time frame: Baseline, Week 1 through 16
| Milestone | Pregabalin | Placebo |
|---|---|---|
| Started | 112 | 108 |
| Treated | 112 | 107 |
| Completed | 93 | 91 |
| Not completed | 19 | 17 |
| Withdrew: Lack of efficacy | 1 | 2 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Protocol violation | 5 | 3 |
| Withdrew: Adverse event | 8 | 8 |
| Withdrew: Other | 2 | 0 |
| Withdrew: Randomized, unknown if treated | 0 | 1 |
DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Duration Adjusted Average Change (DAAC) of Mean Pain Score | -1.66 ± 0.157 | -1.07 ± 0.149 |
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline | 6.5 ± 1.45 | 6.5 ± 1.41 |
| Change from baseline at endpoint | -1.9 ± 1.91 | -1.2 ± 1.78 |
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
| participants | Pregabalin | Placebo |
|---|---|---|
| Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline | 48 | 33 |
The PGIC is a participant-rated instrument measuring change in the participant's overall status on a 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
| participants | Pregabalin | Placebo |
|---|---|---|
| 1-Very much improved | 7 | 2 |
| 2-Much improved | 33 | 25 |
| 3-Minimally improved | 38 | 24 |
| 4-No change | 19 | 40 |
| 5-Minimally worse | 2 | 5 |
| 6-Much worse | 0 | 3 |
| 7-Very much worse | 1 | 0 |
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]).
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 105, 105) | 4.9 ± 2.48 | 5.2 ± 2.24 |
| Change from baseline at endpoint (n = 105, 104) | -2.0 ± 2.35 | -1.0 ± 1.77 |
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 111, 108) | 6.44 ± 1.44 | 6.51 ± 1.40 |
| Change at Week 1 (n = 111, 107) | -0.85 ± 1.04 | -0.38 ± 0.89 |
| Change at Week 2 (n = 110, 105) | -1.26 ± 1.21 | -0.62 ± 1.30 |
| Change at Week 3 (n = 107, 105) | -1.35 ± 1.35 | -0.86 ± 1.35 |
| Change at Week 4 (n = 107, 103) | -1.64 ± 1.61 | -1.03 ± 1.53 |
| Change at Week 5 (n = 105, 101) | -1.87 ± 1.73 | -1.07 ± 1.50 |
| Change at Week 6 (n = 105, 99) | -1.89 ± 1.90 | -1.22 ± 1.72 |
| Change at Week 7 (n = 103, 98) | -2.02 ± 1.86 | -1.34 ± 1.75 |
| Change at Week 8 (n = 101, 97) | -1.96 ± 1.82 | -1.32 ± 1.82 |
| Change at Week 9 (n = 98, 97) | -1.99 ± 1.81 | -1.37 ± 1.75 |
| Change at Week 10 (n = 97, 91) | -2.03 ± 1.75 | -1.32 ± 1.81 |
| Change at Week 11 (n = 96, 90) | -2.04 ± 1.82 | -1.43 ± 1.84 |
| Change at Week 12 (n = 96, 91) | -1.90 ± 1.83 | -1.44 ± 1.93 |
| Change at Week 13 (n = 93, 91) | -2.02 ± 1.76 | -1.39 ± 1.92 |
| Change at Week 14 (n = 93, 92) | -2.00 ± 1.76 | -1.34 ± 1.89 |
| Change at Week 15 (n = 93, 92) | -2.09 ± 1.80 | -1.41 ± 1.85 |
| Change at Week 16 (n = 89, 90) | -2.17 ± 1.78 | -1.36 ± 1.87 |
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
| participants | Pregabalin | Placebo |
|---|---|---|
| Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline | 31 | 16 |
Pain related sleep interference was assessed on an 11 point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]).
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 111, 107) | 4.86 ± 2.46 | 5.18 ± 2.23 |
| Change at Week 1 (n = 111, 106) | -0.96 ± 1.45 | -0.26 ± 0.85 |
| Change at Week 2 (n = 110, 104) | -1.29 ± 1.63 | -0.49 ± 1.17 |
| Change at Week 3 (n = 107, 104) | -1.36 ± 1.68 | -0.61 ± 1.27 |
| Change at Week 4 (n = 107, 102) | -1.59 ± 1.85 | -0.90 ± 1.45 |
| Change at Week 5 (n = 105, 100) | -1.81 ± 2.05 | -0.91 ± 1.38 |
| Change at Week 6 (n = 105, 98) | -1.86 ± 2.14 | -0.99 ± 1.48 |
| Change at Week 7 (n = 103, 97) | -1.98 ± 2.19 | -1.10 ± 1.50 |
| Change at Week 8 (n = 101, 96) | -1.97 ± 2.18 | -1.11 ± 1.59 |
| Change at Week 9 (n = 98, 96) | -2.03 ± 2.13 | -1.11 ± 1.72 |
| Change at Week 10 (n = 97, 90) | -2.18 ± 2.06 | -1.12 ± 1.74 |
| Change at Week 11 (n = 96, 89) | -2.08 ± 2.15 | -1.20 ± 1.85 |
| Change at Week 12 (n = 96, 90) | -2.07 ± 2.21 | -1.20 ± 1.75 |
| Change at Week 13 (n = 93, 90) | -2.08 ± 2.21 | -1.19 ± 1.82 |
| Change at Week 14 (n = 93, 91) | -2.09 ± 2.13 | -1.18 ± 1.83 |
| Change at Week 15 (n = 93, 91) | -2.15 ± 2.10 | -1.11 ± 1.83 |
| Change at Week 16 (n = 89, 89) | -2.25 ± 2.24 | -1.17 ± 1.82 |
The Modified Brief Pain Inventory (mBPI-10) Interference Scale is a self administered questionnaire that assessed pain interference with functional activities over the past week. The items were measured on an 11 point scale, ranging from "does not interfere" (0) to "completely interferes" (10). A composite score, the pain interference index, was calculated by averaging the 10 items that comprised the scale.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline | 4.7 ± 2.18 | 4.9 ± 2.21 |
| Change from baseline at endpoint (n = 100, 99) | -1.6 ± 2.19 | -1.1 ± 2.02 |
Participant rated pain scale. The pain produced by the applied stimulus (static mechanical allodynia - gentle constant mechanical pressure) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 83, 82) | 2.9 ± 3.16 | 2.6 ± 2.95 |
| Change from baseline at endpoint (n = 79, 75) | -1.0 ± 2.69 | -0.3 ± 2.48 |
Participant rated pain scale. The pain produced by the applied stimulus (dynamic mechanical allodynia - gentle stroking with foam brush) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 83, 82) | 2.7 ± 2.81 | 2.3 ± 2.84 |
| Change from baseline at endpoint (n = 79, 75) | -0.6 ± 2.35 | -0.3 ± 2.32 |
Participant rated pain scale. The pain produced by the applied stimulus (Punctata hyperalgesia - pinprick) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n=83,82) | 3.9 ± 3.41 | 3.4 ± 3.19 |
| Change from baseline at endpoint (n=79,75) | -1.0 ± 2.36 | -0.4 ± 2.15 |
Participant rated pain scale. The pain produced by the applied stimulus (Temporal summation to tactile stimuli - repeated touching/tapping) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 83, 82) | 4.1 ± 3.54 | 3.9 ± 3.48 |
| Change from baseline at endpoint (n = 79, 75) | -0.5 ± 2.21 | -0.8 ± 2.37 |
Participant rated pain scale. The pain produced by the applied stimulus (Cold allodynia - touch with cool metal rod 13-17 degrees celsius was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 83, 82) | 2.5 ± 2.97 | 2.7 ± 3.13 |
| Change from baseline at endpoint (n = 79, 72) | -0.1 ± 2.12 | 0.4 ± 2.66 |
Participant rated pain scale. The pain produced by the applied stimulus (Cold hyperalgesia - touch with cold metal rod 4 degrees celsius) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 83, 82) | 2.8 ± 3.18 | 2.8 ± 3.25 |
| Change from baseline at endpoint (n = 79, 72) | -0.1 ± 2.60 | 0.4 ± 2.82 |
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 104, 106) | 0.4 ± 0.20 | 0.4 ± 0.22 |
| Change from baseline at endpoint (n = 99, 99) | -0.1 ± 0.21 | -0.1 ± 0.17 |
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline | 0.5 ± 0.32 | 0.5 ± 0.30 |
| Change from baseline at endpoint (n = 100, 99) | -0.1 ± 0.34 | -0.1 ± 0.28 |
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline | 0.4 ± 0.31 | 0.4 ± 0.31 |
| Change from baseline at endpoint (n = 100, 99) | -0.1 ± 0.28 | -0.0 ± 0.26 |
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline | 0.4 ± 0.29 | 0.3 ± 0.30 |
| Change from baseline at endpoint (n = 100, 99) | -0.1 ± 0.31 | -0.1 ± 0.26 |
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline | 0.4 ± 0.29 | 0.4 ± 0.29 |
| Change from baseline at endpoint (n = 100, 99) | -0.1 ± 0.24 | -0.1 ± 0.22 |
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 104, 106) | 0.5 ± 0.28 | 0.5 ± 0.28 |
| Change from baseline at endpoint (n = 99, 99) | -0.1 ± 0.29 | -0.1 ± 0.27 |
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| 1- Burning pain (n = 100, 99) | -1.39 ± 3.420 | -1.00 ± 2.825 |
| 2- Squeezing pain (n = 100, 99) | -1.04 ± 3.181 | -0.41 ± 3.110 |
| 3- Pain like pressure (n = 100, 99) | -0.73 ± 3.429 | -0.20 ± 3.326 |
| 5- Electric shocks (n = 100, 99) | -1.77 ± 3.426 | -0.68 ± 3.664 |
| 6- Stabbing pain (n = 100, 99) | -1.13 ± 3.541 | -0.52 ± 2.804 |
| 8- By light touching (n = 100, 99) | -0.78 ± 3.080 | -0.94 ± 2.683 |
| 9- By pressure (n = 100, 99) | -1.22 ± 2.784 | -1.10 ± 2.675 |
| 10- By something cold (n = 100, 99) | -0.89 ± 3.372 | -0.52 ± 2.459 |
| 11- Pins and needles (n = 99, 99) | -1.01 ± 3.125 | -0.62 ± 3.269 |
| 12- Tingling (n = 99, 99) | -0.99 ± 3.559 | -0.83 ± 3.034 |
NPSI - Temporal item which assesses the duration (number of hours during the last 24 hours) of spontaneous ongoing pain. Improved duration would be a decrease in the number of hours of spontaneous ongoing pain during the last 24 hours compared to baseline.
| participants | Pregabalin | Placebo |
|---|---|---|
| Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4) | 39 | 28 |
NPSI - Temporal item which assesses the paroxysmal pain (number of pain attacks during the last 24 hours). Improvement in the number of attacks would be a decrease in the number of paroxysms during the last 24 hours compared to baseline.
| participants | Pregabalin | Placebo |
|---|---|---|
| Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7) | 48 | 38 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 105, 103) | 45.7 ± 18.02 | 45.9 ± 19.00 |
| Change from baseline at endpoint (n = 100, 95) | -10.8 ± 16.70 | -5.8 ± 16.21 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 105, 104) | 51.9 ± 25.88 | 51.2 ± 26.68 |
| Change from baseline at endpoint (n = 100, 97) | -17.3 ± 25.25 | -8.0 ± 21.70 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 105, 104) | 42.3 ± 25.92 | 43.8 ± 26.92 |
| Change from baseline at endpoint (n = 100, 97) | 11.6 ± 27.26 | 5.7 ± 28.83 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 105, 104) | 31.2 ± 34.07 | 35.6 ± 35.47 |
| Change from baseline at endpoint (n = 100, 97) | 2.2 ± 25.88 | -4.7 ± 27.50 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 105, 105) | 15.0 ± 23.00 | 12.8 ± 23.23 |
| Change from baseline at endpoint (n = 100, 98) | -6.2 ± 22.33 | -0.2 ± 22.52 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 104,105) | 5.9 ± 1.45 | 6.2 ± 1.64 |
| Change from baseline at endpoint (n = 100, 98) | 0.6 ± 1.42 | 0.2 ± 1.29 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n = 105, 105) | 36.3 ± 19.81 | 39.7 ± 23.43 |
| Change from baseline at endpoint (n = 100, 97) | -0.8 ± 20.64 | -4.9 ± 22.31 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
| participants | Pregabalin | Placebo |
|---|---|---|
| Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS) | 49 | 30 |
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.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline | 6.7 ± 4.41 | 6.9 ± 4.12 |
| Change from baseline at endpoint (n = 100, 99) | -1.4 ± 3.21 | -0.8 ± 3.55 |
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.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Baseline | 5.2 ± 3.96 | 6.3 ± 3.99 |
| Change from baseline at endpoint (n = 100, 99) | -1.0 ± 3.44 | -0.5 ± 3.56 |
Collected over Baseline up to and including 28 calendar days after the last administration of the study treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregabalin | — | 9/112 (8%) | 78/112 (69.6%) |
| Placebo | — | 10/107 (9.3%) | 56/107 (52.3%) |
| Event | Pregabalin | Placebo |
|---|---|---|
| PneumoniaInfections and infestations | 3/112 | 0/107 |
| Ear haemorrhageEar and labyrinth disorders | 0/112 | 1/107 |
| CholecystitisHepatobiliary disorders | 0/112 | 1/107 |
| Osteomyelitis chronicInfections and infestations | 0/112 | 1/107 |
| Pyelonephritis acuteInfections and infestations | 0/112 | 1/107 |
| Urinary tract infectionInfections and infestations | 0/112 | 1/107 |
| FallInjury, poisoning and procedural complications | 0/112 | 1/107 |
| Head injuryInjury, poisoning and procedural complications | 0/112 | 1/107 |
| Back painMusculoskeletal and connective tissue disorders | 0/112 | 1/107 |
| PeriarthritisMusculoskeletal and connective tissue disorders | 0/112 | 1/107 |
| Event | Pregabalin | Placebo |
|---|---|---|
| SomnolenceNervous system disorders | 37/112 | 14/107 |
| DizzinessNervous system disorders | 22/112 | 6/107 |
| Urinary tract infectionInfections and infestations | 12/112 | 17/107 |
| Oedema peripheralGeneral disorders | 15/112 | 5/107 |
| NasopharyngitisInfections and infestations | 13/112 | 8/107 |
| FatigueGeneral disorders | 10/112 | 3/107 |
| Dry mouthGastrointestinal disorders | 9/112 | 3/107 |
| HeadacheNervous system disorders | 8/112 | 5/107 |
| Vision blurredEye disorders | 7/112 | 0/107 |
| InsomniaPsychiatric disorders | 7/112 | 4/107 |
| Age, Continuous(years) | Pregabalin | Placebo | Total |
|---|---|---|---|
| Mean | 46.1 ± 12.7 | 45.6 ± 13.8 | 45.9 ± 13.3 |
| Age, Customized(participants) | Pregabalin | Placebo | Total |
|---|---|---|---|
| Between 18 and 44 years | 52 | 53 | 105 |
| Between 45 and 64 years | 50 | 45 | 95 |
| >= 65 years | 9 | 10 | 19 |
| Sex: Female, Male(Participants) | Pregabalin | Placebo | Total |
|---|---|---|---|
| Female | 27 | 16 | 43 |
| Male | 84 | 92 | 176 |
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.