Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00991276 | Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance | PHASE3 | COMPLETED | 85 | — | — | Dec 1, 2009 | Jun 1, 2011 | Feb 15, 2021 | 41 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| pregabalin | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| pramipexole | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| pregabalin | DRUG | capsules; 300 mg once-per-day; 4 weeks of treatment |
| 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 |
Inclusion Criteria: * Diagnosis of restless legs syndrome with a total score of 15 or more points on the International RLS rating scale (IRLS). * RLS symptoms interfering with sleep on 3 or more nights per week for at least 6 months. * PSG confirmation of WASO of at least 60 min, PLMI of 10 or more...