A Phase 3 interventional study of pregabalin and placebo in Restless Legs Syndrome, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 41 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-15.
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 assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 85 is close to the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation 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
Drug: pramipexole
capsules; 300 mg once-per-day; 4 weeks of treatment
Also known as: Lyrica
capsules; 0 mg once-per-day; 4 weeks of treatment
capsules; 0.5 mg once-per-day; 4 weeks of treatment
Also known as: Mirapex
Wake After Sleep Onset (WASO)
WASO as determined by Polysomnography (PSG) was time spent awake from sleep onset to final awakening. WASO= Wake Time During Sleep \[WTDS\] epochs + Wake Time After Sleep \[WTAS\] epochs)/2. WTDS: number of wake epochs (30 seconds of PSG recording) after onset of persistent sleep and prior to final awakening or end of 8-hour recording/2 and WTAS: number of wake epochs after final awakening until end of the 8-hour recording/2. WASO was measured on 2 consecutive days within a period. Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or Early Termination (ET)
Periodic Limb Movement Arousal Index (PLMAI)
PLMAI, as determined by PSG was number of periodic limb movements leading to arousal per hour (per hour of Total Sleep Time \[TST\]). Arithmetic mean of PLMAI of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Subjective Total Sleep Time (sTST)
sTST as derived from Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Completed by the participant 30 minutes after waking; recall period is the night before. Arithmetic mean of sTST of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 3 and Week 5 of Each Intervention Period or ET
Minutes of Stage N1, N2, N3 and R Sleep
Minutes of Stage 1 Non-Rapid Eye Movement (Non-REM) sleep (Stage N1), Stage 2 Non-REM sleep (Stage N2), Stage 3 Non-REM sleep (Stage N3) or Slow Wave Sleep (SWS) and Stage REM (Stage R) sleep, as determined by PSG were calculated as total number of Stage N1 30-second (30-sec) epochs divided by 2, total number of Stage N2 30-sec epochs divided by 2, total number of Stage N3 30-sec epochs divided by 2 and total number of Stage R 30-sec epochs divided by 2 respectively. Arithmetic mean of minutes of stage N1, N2, N3 and R sleep of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)
NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage 2 Non-REM \[Stage N2\] 30-second (30-sec) epoch, Stage 3 Non-REM \[Stage N3\] 30-sec epoch, or stage rapid eye movement \[stage R\] 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Restless Legs Syndrome-Next Day Impact (RLS-NDI)
RLS-NDI:participant-rated instrument to assess daytime performance and participant's previous night's sleep, consists of 14 items encompassing 5 domains:tiredness;emotional functioning;social functioning;cognitive functioning;activities of daily living and 1 global item for overall well-being. Each item: 0-10 scale; 0=Not at all; 10=Extremely. Total score: sum of scores from question 1-14 (question 10, 11: scores reversed). Total score range: 0-140; higher scores: more severe impact. Arithmetic mean of RLS-NDI of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 3 and Week 5 of Each Intervention Period or ET
Periodic Limb Movement Index (PLMI)
PLMI, as determined by PSG was number of periodic limb movements per hour based on time in bed (TIB). Arithmetic mean of PLMI of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Periodic Limb Movement in Sleep Index (PLMSI)
PLMSI, as determined by PSG was number of periodic limb movements in sleep per hour based on TST. Arithmetic mean of PLMSI of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2)
NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Number of Arousals (NASO)
NASO, as determined by PSG, was calculated as number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NASO of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Arousal Index (NASOI)
Arousal index, as determined by PSG, was NASO per hours of sleep from the onset of persistent sleep to light on. Arithmetic mean of NASOI of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
International Restless Legs Syndrome Study Group Rating Scale (IRLS)
IRLS: psychometrically; clinically valid; clinician-administered instrument assesses severity of RLS. RLS symptom severity and impact on daily living comprise of 10 items giving 2 subscale scores and 1 global score. Subscale scores: symptom severity(6 items) and impact on daily living(3 items), item 3 loaded equally on both subscales. Global score calculated from 10 items. Score of all items range from 0-4, total score range:0-40. Lower scores: lower severity and better quality of life. Arithmetic mean of IRLS of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) Scale
CGI-I: 7-point clinician rated scale to assess improvement in disease condition as compared to the start of the study medication (baseline), ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved). Higher score = more affected.
Time frame: Baseline, Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Latency to Stage R Sleep (LREM)
LREM, as determined by PSG, was number of non-wake epochs from the beginning of the recording to the first occurrence of Stage R sleep divided by 2. Arithmetic mean of LREM of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Latency to Persistent Sleep (LPS)
LPS, as determined by PSG, was number of epochs from the beginning of the recording ("lights-out") to the start of the first 20 consecutive non-wake epochs (10 minutes of persistent sleep) divided by 2. Arithmetic mean of LPS of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Wake Time During Sleep (WTDS)
WTDS, as determined by PSG, was the number of wake (30-sec) epochs after the onset of persistent sleep and prior to the final awakening or at the end of 8-hour recording. WTDS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTDS of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Wake Time After Sleep (WTAS)
WTAS, as determined by PSG, was the number of wake (30-sec) epochs after the final awakening until the end of the 8-hour recording. WTAS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTAS of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Total Sleep Time (TST)
TST, as determined by PSG, was the number of non-wake (30-sec) epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of TST of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Sleep Efficiency (SE)
SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of SE of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Hourly and Quarterly Assessment of Wake After Sleep Onset (WASO)
WASO, as determined by PSG was time spent awake from sleep onset to final awakening. WASO = (sum of WTDS 30-sec epochs and WTAS 30-sec epochs)/2, measured on 2 consecutive days at end of each intervention period by each individual hour (8 hours total) and each individual quarter of night (eight hours in 2 hour increments). Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Hourly and Quarterly Assessment of Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)
NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 30-sec epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Hourly and Quarterly Assessment of Number of Awakenings of at Least 2 Epoch After Sleep Onset (NAASO2)
NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Hourly and Quarterly Assessment of Number of Arousals (NASO)
NASO, as determined by PSG was the number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NASO for each participant at each period was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Hourly and Quarterly Assessment of Periodic Limb Movement (PLM)
PLM, as determined by PSG was number of periodic limb movements based on time in bed (TIB). Calculated at each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of PLM of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Hourly and Quarterly Assessment of Sleep Efficiency (SE)
SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean for SE of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale
SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This (1 item) subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 awakenings to 30 awakenings. Lower value indicates better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.
Time frame: Week 3 and Week 5 of Each Intervention Period or ET
Subjective Sleep Questionnaire (SSQ): Total Wake Time After Sleep Onset Subscale
SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale (in minutes): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0-1440 minutes. Lower value: better sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.
Time frame: Week 3 and Week 5 of each intervention period or ET
Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale
SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before, Range: 0 to 100, higher score: better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.
Time frame: Week 3 and Week 5 of each intervention period or ET
Subjective Sleep Questionnaire (SSQ): Latency Subscale
SSQ: participant-rated instrument assesses sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. Latency (time to fall asleep \[in minutes\]): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 - 840 minutes, lower value: better sleep. Arithmetic mean of subscale score of each participant for all periods was taken prior to employing linear mixed model. Hours of sleep subscale results reported as sTST.
Time frame: Week 3 and Week 5 of each intervention period or ET
Medical Outcomes Study - Sleep Scale (MOS-SS)
MOS-SS:Participant rated instrument, assesses sleep quantity, quality;with 12 items(7 subscale scores:sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep;2 composite index scores:sleep problems Index I, II). Subscale scores total range:0-100(except sleep quantity\[range 0-24 hours\], optimal sleep\[range 0-1: 0= \<7 or \>8 hours;1=7/8 hours\]). Higher scores=poorer sleep outcomes(except sleep quantity, adequacy). Arithmetic mean of MOS-SS scores of each participant for all periods was taken before linear mixed model analysis.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Restless Leg Syndrome - Quality of Life Scale (RLS-QoL)
RLS-QoL: psychometrically and clinically valid and reliable participant-rated instrument, assesses impact of RLS on participant quality of life. Specifically, it assessed effects of RLS on health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, travelling, sexual activity, and work) giving a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period: 1 week prior to assessment. Arithmetic mean of RLS-QoL score of each participant for all periods was taken prior to employing linear mixed model.
Time frame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Milestone | Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg | Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo | Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg | Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo | Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg | Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg |
|---|---|---|---|---|---|---|
| Started | 15 | 13 | 14 | 15 | 15 | 13 |
| Completed | 15 | 10 | 14 | 11 | 11 | 12 |
| Not completed | 0 | 3 | 0 | 4 | 4 | 1 |
| Withdrew: Adverse event | 0 | 1 | 0 | 1 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 2 | 0 |
| Withdrew: Insufficient clinical response | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Other | 0 | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 1 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 1 | 0 | 0 |
| Milestone | Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg | Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo | Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg | Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo | Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg | Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg |
|---|---|---|---|---|---|---|
| Started | 15 | 10 | 14 | 11 | 11 | 12 |
| Completed | 15 | 10 | 14 | 11 | 11 | 12 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg | Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo | Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg | Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo | Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg | Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg |
|---|---|---|---|---|---|---|
| Started | 15 | 10 | 14 | 11 | 11 | 12 |
| Completed | 14 | 8 | 14 | 9 | 10 | 11 |
| Not completed | 1 | 2 | 0 | 2 | 1 | 1 |
| Withdrew: Adverse event | 0 | 2 | 0 | 1 | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Other | 0 | 0 | 0 | 1 | 0 | 1 |
| Milestone | Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg | Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo | Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg | Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo | Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg | Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg |
|---|---|---|---|---|---|---|
| Started | 14 | 8 | 14 | 9 | 10 | 11 |
| Completed | 14 | 8 | 14 | 9 | 10 | 11 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg | Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo | Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg | Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo | Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg | Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg |
|---|---|---|---|---|---|---|
| Started | 14 | 8 | 14 | 9 | 10 | 11 |
| Completed | 13 | 8 | 13 | 8 | 10 | 10 |
| Not completed | 1 | 0 | 1 | 1 | 0 | 1 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 0 | 0 |
WASO as determined by Polysomnography (PSG) was time spent awake from sleep onset to final awakening. WASO= Wake Time During Sleep \[WTDS\] epochs + Wake Time After Sleep \[WTAS\] epochs)/2. WTDS: number of wake epochs (30 seconds of PSG recording) after onset of persistent sleep and prior to final awakening or end of 8-hour recording/2 and WTAS: number of wake epochs after final awakening until end of the 8-hour recording/2. WASO was measured on 2 consecutive days within a period. Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model.
| minutes | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Wake After Sleep Onset (WASO) | 51.50 (43.20 to 59.79) | 78.42 (70.34 to 86.51) | 78.60 (70.29 to 86.90) |
PLMAI, as determined by PSG was number of periodic limb movements leading to arousal per hour (per hour of Total Sleep Time \[TST\]). Arithmetic mean of PLMAI of each participant for all periods was taken prior to employing linear mixed model.
| movement/hour | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Periodic Limb Movement Arousal Index (PLMAI) | 3.93 (2.49 to 5.36) | 2.66 (1.27 to 4.06) | 7.61 (6.17 to 9.04) |
sTST as derived from Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Completed by the participant 30 minutes after waking; recall period is the night before. Arithmetic mean of sTST of each participant for all periods was taken prior to employing linear mixed model.
| minutes | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Subjective Total Sleep Time (sTST) | 400.97 (386.36 to 415.58) | 374.19 (360.00 to 388.37) | 370.16 (355.69 to 384.63) |
Minutes of Stage 1 Non-Rapid Eye Movement (Non-REM) sleep (Stage N1), Stage 2 Non-REM sleep (Stage N2), Stage 3 Non-REM sleep (Stage N3) or Slow Wave Sleep (SWS) and Stage REM (Stage R) sleep, as determined by PSG were calculated as total number of Stage N1 30-second (30-sec) epochs divided by 2, total number of Stage N2 30-sec epochs divided by 2, total number of Stage N3 30-sec epochs divided by 2 and total number of Stage R 30-sec epochs divided by 2 respectively. Arithmetic mean of minutes of stage N1, N2, N3 and R sleep of each participant for all periods was taken prior to employing linear mixed model.
| minutes | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Stage N1 Sleep | 38.06 (32.97 to 43.14) | 48.38 (43.38 to 53.38) | 43.72 (38.63 to 48.81) |
| Stage N2 Sleep | 227.05 (215.01 to 239.09) | 241.52 (229.76 to 253.27) | 204.35 (192.29 to 216.40) |
| Stage N3 Sleep/SWS | 66.88 (57.78 to 75.98) | 34.78 (25.87 to 43.69) | 45.95 (36.85 to 55.06) |
| Stage R Sleep | 70.40 (64.32 to 76.48) | 51.80 (45.86 to 57.75) | 75.37 (69.29 to 81.45) |
NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage 2 Non-REM \[Stage N2\] 30-second (30-sec) epoch, Stage 3 Non-REM \[Stage N3\] 30-sec epoch, or stage rapid eye movement \[stage R\] 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model.
| awakenings | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1) | 18.43 (16.49 to 20.36) | 26.30 (24.41 to 28.19) | 21.10 (19.16 to 23.04) |
RLS-NDI:participant-rated instrument to assess daytime performance and participant's previous night's sleep, consists of 14 items encompassing 5 domains:tiredness;emotional functioning;social functioning;cognitive functioning;activities of daily living and 1 global item for overall well-being. Each item: 0-10 scale; 0=Not at all; 10=Extremely. Total score: sum of scores from question 1-14 (question 10, 11: scores reversed). Total score range: 0-140; higher scores: more severe impact. Arithmetic mean of RLS-NDI of each participant for all periods was taken prior to employing linear mixed model.
| units on a scale | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Restless Legs Syndrome-Next Day Impact (RLS-NDI) | 41.43 (35.36 to 47.50) | 46.33 (40.39 to 52.27) | 46.78 (40.75 to 52.81) |
PLMI, as determined by PSG was number of periodic limb movements per hour based on time in bed (TIB). Arithmetic mean of PLMI of each participant for all periods was taken prior to employing linear mixed model.
| movement/hour | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Periodic Limb Movement Index (PLMI) | 25.45 (20.99 to 29.91) | 14.11 (9.79 to 18.42) | 39.95 (35.48 to 44.41) |
PLMSI, as determined by PSG was number of periodic limb movements in sleep per hour based on TST. Arithmetic mean of PLMSI of each participant for all periods was taken prior to employing linear mixed model.
| movement/hour | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Periodic Limb Movement in Sleep Index (PLMSI) | 22.42 (17.46 to 27.39) | 8.00 (3.20 to 12.80) | 36.95 (31.99 to 41.92) |
NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model.
| awakenings | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2) | 7.68 (6.55 to 8.82) | 12.39 (11.28 to 13.50) | 10.55 (9.42 to 11.68) |
NASO, as determined by PSG, was calculated as number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NASO of each participant for all periods was taken prior to employing linear mixed model.
| arousals | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Number of Arousals (NASO) | 17.84 (15.06 to 20.61) | 24.19 (21.47 to 26.90) | 20.29 (17.51 to 23.06) |
Arousal index, as determined by PSG, was NASO per hours of sleep from the onset of persistent sleep to light on. Arithmetic mean of NASOI of each participant for all periods was taken prior to employing linear mixed model.
| arousals/hour | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Arousal Index (NASOI) | 2.75 (2.23 to 3.28) | 4.18 (3.67 to 4.69) | 3.44 (2.92 to 3.96) |
IRLS: psychometrically; clinically valid; clinician-administered instrument assesses severity of RLS. RLS symptom severity and impact on daily living comprise of 10 items giving 2 subscale scores and 1 global score. Subscale scores: symptom severity(6 items) and impact on daily living(3 items), item 3 loaded equally on both subscales. Global score calculated from 10 items. Score of all items range from 0-4, total score range:0-40. Lower scores: lower severity and better quality of life. Arithmetic mean of IRLS of each participant for all periods was taken prior to employing linear mixed model.
| units on a scale | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| International Restless Legs Syndrome Study Group Rating Scale (IRLS) | 12.28 (10.32 to 14.24) | 15.35 (13.42 to 17.28) | 18.38 (16.42 to 20.34) |
CGI-I: 7-point clinician rated scale to assess improvement in disease condition as compared to the start of the study medication (baseline), ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved). Higher score = more affected.
| percentage of participants | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) Scale | 61.2 | 50.0 | 33.3 |
LREM, as determined by PSG, was number of non-wake epochs from the beginning of the recording to the first occurrence of Stage R sleep divided by 2. Arithmetic mean of LREM of each participant for all periods was taken prior to employing linear mixed model.
| minutes | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Latency to Stage R Sleep (LREM) | 95.22 (82.11 to 108.33) | 130.99 (118.26 to 143.72) | 84.52 (71.40 to 97.64) |
LPS, as determined by PSG, was number of epochs from the beginning of the recording ("lights-out") to the start of the first 20 consecutive non-wake epochs (10 minutes of persistent sleep) divided by 2. Arithmetic mean of LPS of each participant for all periods was taken prior to employing linear mixed model.
| minutes | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Latency to Persistent Sleep (LPS) | 31.13 (22.06 to 40.19) | 31.52 (22.68 to 40.36) | 38.86 (29.78 to 47.93) |
WTDS, as determined by PSG, was the number of wake (30-sec) epochs after the onset of persistent sleep and prior to the final awakening or at the end of 8-hour recording. WTDS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTDS of each participant for all periods was taken prior to employing linear mixed model.
| minutes | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Wake Time During Sleep (WTDS) | 45.77 (37.81 to 53.73) | 70.51 (62.77 to 78.25) | 69.75 (61.78 to 77.72) |
WTAS, as determined by PSG, was the number of wake (30-sec) epochs after the final awakening until the end of the 8-hour recording. WTAS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTAS of each participant for all periods was taken prior to employing linear mixed model.
| minutes | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Wake Time After Sleep (WTAS) | 5.58 (2.15 to 9.00) | 7.86 (4.53 to 11.19) | 8.88 (5.45 to 12.30) |
TST, as determined by PSG, was the number of non-wake (30-sec) epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of TST of each participant for all periods was taken prior to employing linear mixed model.
| minutes | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Total Sleep Time (TST) | 402.38 (390.60 to 414.15) | 376.52 (364.99 to 388.05) | 369.66 (357.88 to 381.44) |
SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of SE of each participant for all periods was taken prior to employing linear mixed model.
| Percentage of time asleep | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Sleep Efficiency (SE) | 83.81 (81.36 to 86.27) | 78.58 (76.17 to 80.98) | 77.02 (74.56 to 79.48) |
WASO, as determined by PSG was time spent awake from sleep onset to final awakening. WASO = (sum of WTDS 30-sec epochs and WTAS 30-sec epochs)/2, measured on 2 consecutive days at end of each intervention period by each individual hour (8 hours total) and each individual quarter of night (eight hours in 2 hour increments). Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model.
| minutes | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Hour 1 (n= 66, 67, 66) | 1.62 ± 4.12 | 2.26 ± 2.69 | 3.35 ± 3.84 |
| Hour 2 (n= 67, 70, 66) | 5.04 ± 6.15 | 7.07 ± 5.48 | 7.39 ± 6.85 |
| Hour 3 (n= 67, 70, 67) | 4.89 (3.14 to 6.64) | 8.23 (6.52 to 9.93) | 8.90 (7.13 to 10.68) |
| Hour 4 (n= 67, 70, 68) | 6.21 (4.29 to 8.13) | 11.54 (9.67 to 13.42) | 9.52 (7.59 to 11.44) |
| Hour 5 (n= 67, 70, 68) | 5.93 (3.80 to 8.06) | 10.39 (8.32 to 12.46) | 10.04 (7.91 to 12.17) |
| Hour 6 (n= 67, 71, 68) | 5.78 (3.49 to 8.08) | 10.54 (8.32 to 12.76) | 10.52 (8.22 to 12.81) |
| Hour 7 (n= 67, 71, 68) | 9.18 (6.72 to 11.64) | 11.44 (9.06 to 13.82) | 12.09 (9.63 to 14.55) |
| Hour 8 (n= 67, 71, 68) | 13.16 (10.09 to 16.23) | 18.27 (15.28 to 21.25) | 18.15 (15.08 to 21.22) |
| Quarter 1 (n= 67, 70, 66) | 6.42 (4.59 to 8.26) | 8.99 (7.20 to 10.78) | 10.35 (8.47 to 12.23) |
| Quarter 2 (n= 67, 70, 68) | 11.08 (8.09 to 14.07) | 19.77 (16.86 to 22.69) | 18.18 (15.19 to 21.17) |
| Quarter 3 (n= 67, 71, 68) | 11.81 (8.03 to 15.59) | 20.77 (17.11 to 24.42) | 20.55 (16.77 to 24.33) |
| Quarter 4 (n= 67, 71, 68) | 22.37 (17.70 to 27.04) | 29.55 (25.00 to 34.10) | 30.21 (25.54 to 34.89) |
NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 30-sec epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model.
| awakenings | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Hour 1 (n= 66, 67, 66) | 0.70 ± 0.90 | 1.39 ± 1.12 | 1.10 ± 0.76 |
| Hour 2 (n= 67, 70, 66) | 2.06 ± 1.41 | 3.32 ± 1.74 | 2.47 ± 1.44 |
| Hour 3 (n= 67, 70, 67) | 2.09 (1.69 to 2.48) | 3.42 (3.03 to 3.81) | 2.66 (2.25 to 3.06) |
| Hour 4 (n= 67, 70, 68) | 2.44 (2.00 to 2.88) | 3.83 (3.40 to 4.25) | 2.71 (2.27 to 3.15) |
| Hour 5 (n= 67, 70, 68) | 2.47 (2.06 to 2.89) | 3.76 (3.36 to 4.17) | 2.87 (2.46 to 3.29) |
| Hour 6 (n= 67, 71, 68) | 2.91 (2.46 to 3.36) | 3.68 (3.24 to 4.12) | 3.16 (2.71 to 3.62) |
| Hour 7 (n= 67, 71, 68) | 3.07 (2.62 to 3.53) | 4.04 (3.60 to 4.47) | 3.32 (2.87 to 3.77) |
| Hour 8 (n= 67, 71, 68) | 2.76 (2.30 to 3.21) | 3.46 (3.02 to 3.90) | 3.11 (2.65 to 3.56) |
| Quarter 1 (n= 67, 70, 66) | 2.71 (2.22 to 3.20) | 4.61 (4.13 to 5.09) | 3.49 (2.98 to 3.99) |
| Quarter 2 (n= 67, 70, 68) | 4.53 (3.86 to 5.21) | 7.27 (6.61 to 7.93) | 5.32 (4.64 to 5.99) |
| Quarter 3 (n= 67, 71, 68) | 5.39 (4.66 to 6.12) | 7.37 (6.66 to 8.08) | 6.04 (5.31 to 6.77) |
| Quarter 4 (n= 67, 71, 68) | 5.87 (5.15 to 6.59) | 7.36 (6.67 to 8.06) | 6.44 (5.73 to 7.16) |
NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model.
| awakenings | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Hour 1 (n= 66, 67, 66) | 0.42 ± 0.60 | 0.61 ± 0.71 | 0.73 ± 0.59 |
| Hour 2 (n= 67, 70, 66) | 1.04 ± 0.83 | 1.72 ± 1.13 | 1.37 ± 1.06 |
| Hour 3 (n= 67, 70, 67) | 0.99 (0.75 to 1.23) | 1.71 (1.48 to 1.95) | 1.41 (1.17 to 1.65) |
| Hour 4 (n= 67, 70, 68) | 1.01 (0.74 to 1.27) | 1.84 (1.58 to 2.09) | 1.48 (1.22 to 1.74) |
| Hour 5 (n= 67, 70, 68) | 1.06 (0.81 to 1.31) | 1.76 (1.52 to 2.01) | 1.48 (1.22 to 1.73) |
| Hour 6 (n= 67, 71, 68) | 1.02 (0.79 to 1.26) | 1.57 (1.34 to 1.80) | 1.44 (1.20 to 1.68) |
| Hour 7 (n= 67, 71, 68) | 1.24 (0.97 to 1.51) | 1.94 (1.68 to 2.20) | 1.57 (1.30 to 1.84) |
| Hour 8 (n= 67, 71, 68) | 1.00 (0.75 to 1.24) | 1.56 (1.32 to 1.79) | 1.28 (1.04 to 1.52) |
| Quarter 1 (n= 67, 70, 66) | 1.43 (1.11 to 1.75) | 2.27 (1.96 to 2.58) | 2.06 (1.73 to 2.38) |
| Quarter 2 (n= 67, 70, 68) | 1.99 (1.58 to 2.39) | 3.56 (3.16 to 3.96) | 2.85 (2.44 to 3.26) |
| Quarter 3 (n= 67, 71, 68) | 2.10 (1.68 to 2.51) | 3.30 (2.89 to 3.70) | 2.92 (2.50 to 3.34) |
| Quarter 4 (n= 67, 71, 68) | 2.25 (1.86 to 2.64) | 3.44 (3.06 to 3.82) | 2.86 (2.47 to 3.25) |
NASO, as determined by PSG was the number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NASO for each participant at each period was taken prior to employing linear mixed model.
| arousals | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Hour 1 (n= 66, 67, 66) | 1.48 ± 1.65 | 2.06 ± 2.22 | 1.79 ± 1.78 |
| Hour 2 (n= 67, 70, 66) | 2.36 ± 2.03 | 3.23 ± 2.15 | 2.68 ± 1.99 |
| Hour 3 (n= 67, 70, 67) | 2.31 (1.75 to 2.87) | 3.23 (2.68 to 3.78) | 2.80 (2.23 to 3.37) |
| Hour 4 (n= 67, 70, 68) | 2.94 (2.39 to 3.49) | 3.41 (2.88 to 3.94) | 2.76 (2.22 to 3.31) |
| Hour 5 (n= 67, 70, 68) | 2.33 (1.76 to 2.90) | 3.20 (2.64 to 3.75) | 2.89 (2.32 to 3.46) |
| Hour 6 (n= 67, 71, 68) | 2.39 (1.88 to 2.90) | 3.30 (2.80 to 3.80) | 2.70 (2.19 to 3.22) |
| Hour 7 (n= 67, 71, 68) | 2.15 (1.67 to 2.63) | 3.28 (2.81 to 3.75) | 2.66 (2.18 to 3.14) |
| Hour 8 (n= 67, 71, 68) | 2.07 (1.56 to 2.57) | 2.98 (2.49 to 3.46) | 2.46 (1.96 to 2.97) |
| Quarter 1 (n= 67, 70, 66) | 3.75 (2.93 to 4.57) | 5.09 (4.28 to 5.89) | 4.26 (3.43 to 5.09) |
| Quarter 2 (n= 67, 70, 68) | 5.25 (4.32 to 6.18) | 6.67 (5.76 to 7.57) | 5.55 (4.62 to 6.48) |
| Quarter 3 (n= 67, 71, 68) | 4.75 (3.86 to 5.64) | 6.44 (5.58 to 7.30) | 5.61 (4.72 to 6.50) |
| Quarter 4 (n= 67, 71, 68) | 4.23 (3.39 to 5.06) | 6.24 (5.43 to 7.04) | 5.13 (4.29 to 5.96) |
PLM, as determined by PSG was number of periodic limb movements based on time in bed (TIB). Calculated at each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of PLM of each participant for all periods was taken prior to employing linear mixed model.
| movement/hour | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Hour 1 | 31.45 ± 29.70 | 21.57 ± 27.03 | 54.67 ± 39.98 |
| Hour 2 | 26.38 ± 29.20 | 12.49 ± 14.51 | 52.93 ± 40.92 |
| Hour 3 | 40.93 (32.38 to 49.48) | 14.05 (5.77 to 22.32) | 48.76 (40.20 to 57.32) |
| Hour 4 | 30.35 (23.05 to 37.64) | 14.50 (7.45 to 21.55) | 46.58 (39.29 to 53.88) |
| Hour 5 | 25.70 (19.02 to 32.38) | 11.93 (5.47 to 18.38) | 36.17 (29.49 to 42.86) |
| Hour 6 | 21.02 (15.01 to 27.04) | 10.57 (4.75 to 16.38) | 32.47 (26.45 to 38.49) |
| Hour 7 | 14.22 (9.06 to 19.37) | 11.11 (6.12 to 16.09) | 27.04 (21.88 to 32.20) |
| Hour 8 | 13.37 (8.54 to 18.20) | 16.55 (11.86 to 21.24) | 20.97 (16.14 to 25.81) |
| Quarter 1 | 57.82 (44.51 to 71.12) | 34.02 (21.14 to 46.91) | 107.56 (94.24 to 120.87) |
| Quarter 2 | 71.29 (56.94 to 85.64) | 28.55 (14.66 to 42.43) | 95.31 (80.95 to 109.67) |
| Quarter 3 | 46.77 (35.42 to 58.11) | 22.49 (11.51 to 33.46) | 68.66 (57.30 to 80.01) |
| Quarter 4 | 27.60 (18.97 to 36.24) | 27.64 (19.28 to 36.00) | 48.01 (39.36 to 56.65) |
SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean for SE of each participant for all periods was taken prior to employing linear mixed model.
| percentage of time asleep | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Hour 1 | 62.31 ± 24.14 | 66.88 ± 24.30 | 57.80 ± 22.90 |
| Hour 2 | 86.13 ± 16.94 | 83.43 ± 16.03 | 77.31 ± 20.49 |
| Hour 3 | 90.22 (86.68 to 93.77) | 84.86 (81.43 to 88.29) | 81.86 (78.32 to 85.40) |
| Hour 4 | 89.41 (85.86 to 92.97) | 79.84 (76.40 to 83.28) | 82.61 (79.05 to 86.16) |
| Hour 5 | 90.00 (86.30 to 93.70) | 81.85 (78.27 to 85.43) | 82.92 (79.22 to 86.63) |
| Hour 6 | 90.33 (86.45 to 94.21) | 81.64 (77.88 to 85.39) | 82.49 (78.61 to 86.38) |
| Hour 7 | 84.70 (80.60 to 88.80) | 80.90 (76.92 to 84.87) | 79.86 (75.76 to 83.96) |
| Hour 8 | 78.07 (72.95 to 83.19) | 69.51 (64.53 to 74.50) | 69.75 (64.63 to 74.88) |
| Quarter 1 | 74.21 (69.69 to 78.73) | 75.15 (70.73 to 79.57) | 67.62 (63.10 to 72.15) |
| Quarter 2 | 89.84 (86.77 to 92.92) | 82.37 (79.38 to 85.35) | 82.30 (79.23 to 85.38) |
| Quarter 3 | 90.09 (86.83 to 93.34) | 81.74 (78.59 to 84.90) | 82.75 (79.49 to 86.01) |
| Quarter 4 | 81.37 (77.45 to 85.28) | 75.16 (71.35 to 78.97) | 74.84 (70.93 to 78.76) |
SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This (1 item) subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 awakenings to 30 awakenings. Lower value indicates better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.
| awakenings | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale | 1.69 (1.34 to 2.03) | 2.64 (2.31 to 2.98) | 2.51 (2.17 to 2.86) |
SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale (in minutes): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0-1440 minutes. Lower value: better sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.
| minutes | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Subjective Sleep Questionnaire (SSQ): Total Wake Time After Sleep Onset Subscale | 53.78 (42.94 to 64.61) | 82.23 (71.76 to 92.70) | 79.09 (68.46 to 89.72) |
SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before, Range: 0 to 100, higher score: better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.
| units on a scale | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale | 6.74 (6.35 to 7.13) | 5.69 (5.31 to 6.06) | 5.70 (5.32 to 6.08) |
SSQ: participant-rated instrument assesses sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. Latency (time to fall asleep \[in minutes\]): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 - 840 minutes, lower value: better sleep. Arithmetic mean of subscale score of each participant for all periods was taken prior to employing linear mixed model. Hours of sleep subscale results reported as sTST.
| minutes | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Subjective Sleep Questionnaire (SSQ): Latency Subscale | 42.49 (34.26 to 50.72) | 40.59 (32.52 to 48.66) | 50.07 (41.89 to 58.25) |
MOS-SS:Participant rated instrument, assesses sleep quantity, quality;with 12 items(7 subscale scores:sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep;2 composite index scores:sleep problems Index I, II). Subscale scores total range:0-100(except sleep quantity\[range 0-24 hours\], optimal sleep\[range 0-1: 0= \<7 or \>8 hours;1=7/8 hours\]). Higher scores=poorer sleep outcomes(except sleep quantity, adequacy). Arithmetic mean of MOS-SS scores of each participant for all periods was taken before linear mixed model analysis.
| units on a scale | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Awaken Short of Breath/with Headache (n= 68,71,69) | 11.59 (6.20 to 16.97) | 13.10 (7.77 to 18.44) | 10.88 (5.49 to 16.27) |
| Adequacy (n= 68,71,69) | 54.96 (48.11 to 61.81) | 43.90 (37.21 to 50.58) | 40.79 (33.93 to 47.65) |
| Somnolence (n= 68,71,69) | 21.28 (17.08 to 25.47) | 21.32 (17.21 to 25.44) | 23.71 (19.51 to 27.90) |
| Sleep Quantity (n= 68,71,69) | 6.43 (5.95 to 6.91) | 6.50 (6.03 to 6.97) | 5.97 (5.49 to 6.46) |
| 6-Item Sleep Problems Index (n= 68,71,69) | 30.69 (25.94 to 35.45) | 37.24 (32.58 to 41.89) | 40.59 (35.83 to 45.34) |
| 9-Item Sleep Problems Index (n= 68,71,69) | 32.75 (28.06 to 37.44) | 37.88 (33.28 to 42.47) | 42.89 (38.20 to 47.59) |
| Optimal Sleep (n= 68,71,69) | 0.43 (0.32 to 0.54) | 0.35 (0.24 to 0.46) | 0.29 (0.18 to 0.40) |
| Sleep Disturbance (n= 68,71,69) | 34.08 (28.11 to 40.06) | 40.19 (34.34 to 46.04) | 48.65 (42.66 to 54.63) |
| Snoring (n= 67,71,68) | 15.27 (10.05 to 20.49) | 15.97 (10.86 to 21.08) | 17.96 (12.75 to 23.17) |
RLS-QoL: psychometrically and clinically valid and reliable participant-rated instrument, assesses impact of RLS on participant quality of life. Specifically, it assessed effects of RLS on health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, travelling, sexual activity, and work) giving a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period: 1 week prior to assessment. Arithmetic mean of RLS-QoL score of each participant for all periods was taken prior to employing linear mixed model.
| units on a scale | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| Restless Leg Syndrome - Quality of Life Scale (RLS-QoL) | 73.30 (69.72 to 76.87) | 70.05 (66.53 to 73.56) | 68.03 (64.45 to 71.61) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregabalin 300 mg | — | 2/75 (2.7%) | 46/75 (61.3%) |
| Pramipexole 0.5 mg | — | 1/76 (1.3%) | 40/76 (52.6%) |
| Placebo | — | 3/73 (4.1%) | 27/73 (37%) |
| Event | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| GastroenteritisInfections and infestations | 0/75 | 0/76 | 1/73 |
| HypokalaemiaMetabolism and nutrition disorders | 0/75 | 0/76 | 1/73 |
| Suicidal ideationPsychiatric disorders | 0/75 | 1/76 | 1/73 |
| Blood pressure orthostatic decreasedInvestigations | 1/75 | 0/76 | 0/73 |
| Dizziness posturalNervous system disorders | 1/75 | 0/76 | 0/73 |
| Deep vein thrombosisVascular disorders | 1/75 | 0/76 | 0/73 |
| Event | Pregabalin 300 mg | Pramipexole 0.5 mg | Placebo |
|---|---|---|---|
| DizzinessNervous system disorders | 18/75 | 2/76 | 1/73 |
| SomnolenceNervous system disorders | 13/75 | 6/76 | 3/73 |
| NauseaGastrointestinal disorders | 4/75 | 6/76 | 1/73 |
| HeadacheNervous system disorders | 4/75 | 6/76 | 5/73 |
| Dry mouthGastrointestinal disorders | 4/75 | 2/76 | 1/73 |
| Upper respiratory tract infectionInfections and infestations | 4/75 | 2/76 | 0/73 |
| Disturbance in attentionNervous system disorders | 4/75 | 0/76 | 0/73 |
| Vision blurredEye disorders | 3/75 | 0/76 | 0/73 |
| ConstipationGastrointestinal disorders | 3/75 | 1/76 | 2/73 |
| Weight increasedInvestigations | 3/75 | 1/76 | 0/73 |
| Age, Customized(participants) | Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg | Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo | Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg | Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo | Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg | Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg | Total |
|---|---|---|---|---|---|---|---|
| Less than 18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 18 to 44 years | 3 | 4 | 1 | 2 | 5 | 3 | 18 |
| 45 to 64 years | 8 | 7 | 11 | 10 | 8 | 8 | 52 |
| Greater than or equal to 65 years | 4 | 2 | 2 | 3 | 2 | 2 | 15 |
| Sex: Female, Male(Participants) | Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg | Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo | Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg | Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo | Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg | Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg | Total |
|---|---|---|---|---|---|---|---|
| Female | 11 | 7 | 8 | 9 | 12 | 7 | 54 |
| Male | 4 | 6 | 6 | 6 | 3 | 6 | 31 |
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.