Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregabalin | Experimental |
| |
| placebo | Placebo Comparator |
| |
| pramipexole | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin | Drug | capsules; 300 mg once-per-day; 4 weeks of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Jasper | Alabama | 35501 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24899755 | Derived | Garcia-Borreguero D, Patrick J, DuBrava S, Becker PM, Lankford A, Chen C, Miceli J, Knapp L, Allen RP. Pregabalin versus pramipexole: effects on sleep disturbance in restless legs syndrome. Sleep. 2014 Apr 1;37(4):635-43. doi: 10.5665/sleep.3558. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg | Placebo (PBO) capsule matched to pramipexole (PPX) 0.5 milligram (mg) once daily or pregabalin (PGB) 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | capsules; 0 mg once-per-day; 4 weeks of treatment |
|
| pramipexole | Drug | capsules; 0.5 mg once-per-day; 4 weeks of treatment |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| Phoenix |
| Arizona |
| 85037 |
| United States |
| Pfizer Investigational Site | Tucson | Arizona | 85712 | United States |
| Pfizer Investigational Site | Little Rock | Arkansas | 72205 | United States |
| Pfizer Investigational Site | Little Rock | Arkansas | 72211 | United States |
| Pfizer Investigational Site | Burlingame | California | 94010 | United States |
| Pfizer Investigational Site | Pasadena | California | 91106 | United States |
| Pfizer Investigational Site | Redlands | California | 92373 | United States |
| Pfizer Investigational Site | San Diego | California | 92103 | United States |
| Pfizer Investigational Site | San Diego | California | 92121 | United States |
| Pfizer Investigational Site | Santa Ana | California | 92705 | United States |
| Pfizer Investigational Site | Santa Monica | California | 90404 | United States |
| Pfizer Investigational Site | Aurora | Colorado | 80012 | United States |
| Pfizer Investigational Site | Hallandale | Florida | 33009 | United States |
| Pfizer Investigational Site | Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | Pembroke Pines | Florida | 33026 | United States |
| Pfizer Investigational Site | Spring Hill | Florida | 34609 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30342 | United States |
| Pfizer Investigational Site | Macon | Georgia | 31201 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| Pfizer Investigational Site | Crestview Hills | Kentucky | 41017 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40513 | United States |
| Pfizer Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| Pfizer Investigational Site | Chevy Chase | Maryland | 20815 | United States |
| Pfizer Investigational Site | Brighton | Massachusetts | 02135 | United States |
| Pfizer Investigational Site | Kalamazoo | Michigan | 49048 | United States |
| Pfizer Investigational Site | Portage | Michigan | 49024 | United States |
| Pfizer Investigational Site | New York | New York | 10019 | United States |
| Pfizer Investigational Site | Hickory | North Carolina | 28601 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27607 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45227 | United States |
| Pfizer Investigational Site | Dublin | Ohio | 43017 | United States |
| Pfizer Investigational Site | Middleburg Heights | Ohio | 44130 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Pfizer Investigational Site | Clarks Summit | Pennsylvania | 18411 | United States |
| Pfizer Investigational Site | Lafayette Hill | Pennsylvania | 19444 | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29201 | United States |
| Pfizer Investigational Site | Austin | Texas | 78731 | United States |
| Pfizer Investigational Site | Austin | Texas | 78756 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75231 | United States |
| FG001 | Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo | PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period. |
| FG002 | Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg | PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period. |
| FG003 | Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo | PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period. |
| FG004 | Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg | PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period. |
| FG005 | Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg | PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Placebo Wash-out Period (7 Days) |
|
| Second Intervention Period |
|
|
| Placebo Wash-out Period (7 Days) |
|
| Third Intervention Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg | Placebo (PBO) capsule matched to pramipexole (PPX) 0.5 milligram (mg) once daily or pregabalin (PGB) 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period. |
| BG001 | Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo | PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period. |
| BG002 | Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg | PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period. |
| BG003 | Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo | PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period. |
| BG004 | Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg | PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period. |
| BG005 | Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg | PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to Treat (ITT) population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | 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) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | movement/hour | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Week 3 and Week 5 of Each Intervention Period or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | awakenings | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 3 and Week 5 of Each Intervention Period or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | movement/hour | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | movement/hour | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | awakenings | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | arousals | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | arousals/hour | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Number | percentage of participants | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of time asleep | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here "n" signifies number of participants analyzed at that particular time point for each arm group respectively. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here "n" signifies number of participants analyzed at that particular time point for each arm group respectively. | Posted | Least Squares Mean | 95% Confidence Interval | awakenings | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here "n" signifies number of participants analyzed at that particular time point for each arm group respectively. | Posted | Least Squares Mean | 95% Confidence Interval | awakenings | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here "n" signifies number of participants analyzed at that particular time point for each arm group respectively. | Posted | Least Squares Mean | 95% Confidence Interval | arousals | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least one dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | movement/hour | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least one dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of time asleep | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | awakenings | Week 3 and Week 5 of Each Intervention Period or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Week 3 and Week 5 of each intervention period or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 3 and Week 5 of each intervention period or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Week 3 and Week 5 of each intervention period or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here "n" signifies number of participants analyzed for particular subscale for each arm group respectively. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET |
|
Not provided
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study. 'At risk population'= who received study treatments in different interventions; PGB=75,PPX=76,PBO=73.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin 300 mg | PGB capsule 300 mg once daily in any intervention period. | 2 | 75 | 46 | 75 | ||
| EG001 | Pramipexole 0.5 mg | PPX capsule 0.5 mg once daily in any intervention period. | 1 | 76 | 40 | 76 | ||
| EG002 | Placebo | PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in any of the intervention period. | 3 | 73 | 27 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood pressure orthostatic decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Excessive eye blinking | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Feeling drunk | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hangover | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood pressure abnormal | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Red cell distribution width increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Serum ferritin decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Motor dysfunction | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Daydreaming | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Distractibility | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dysphoria | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Euphoric mood | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Libido increased | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Middle insomnia | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Orgasm abnormal | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Urine flow decreased | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Endodontic procedure | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sinus operation | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D000077487 | Pramipexole |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Protocol Violation |
|
| Other |
|
| Other |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
| 18 to 44 years |
|
| 45 to 64 years |
|
| Greater than or equal to 65 years |
|
| Male |
|
| Superiority or Other (legacy) |
| P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance. | Mixed Models Analysis | <0.0001 | This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error. | LS Mean Difference | -26.93 | Standard Error of the Mean | 4.35 | 2-Sided | 95 | -35.54 | -18.32 | Superiority or Other (legacy) |
| P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance. | Mixed Models Analysis | 0.9684 | This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error. | LS Mean Difference | -0.17 | Standard Error of the Mean | 4.32 | 2-Sided | 95 | -8.72 | 8.38 | Superiority or Other (legacy) |
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period. |
|
|
|
PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period. |
|
|
|
PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Placebo |
PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period. |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| OG002 |
| Placebo |
PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period. |
|
|
| OG002 |
| Placebo |
PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period. |
|
|
PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
|
|
|
|
|
|
PBO capsule matched to PPX 0.5 mg once daily in any intervention period. |
|
|
|
PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
|
|
|
PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
|
|
|
PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
|
|
|
| Placebo |
PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period. |
|
|
|
PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period. |
|
|
|