Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
pramipexole · 1 trial · 1 indication
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...
Pramipexole is a small molecule being developed for Restless Legs Syndrome, a neurological condition. It is currently in Phase 3 clinical development and is being studied for its effects on sleep disturbance associated with the condition.
Pramipexole is being developed by Pfizer, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol PFE on the stock exchange.
Pramipexole is in Phase 3 clinical development for Restless Legs Syndrome. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed.
Pramipexole has been studied in a completed Phase 3 clinical trial with the identifier NCT00991276. This trial was a randomized, double-blind, placebo-controlled study that enrolled 85 participants with Restless Legs Syndrome and associated sleep disturbance.
Pramipexole is a small molecule being investigated for Restless Legs Syndrome. The specific molecular target of pramipexole has not been disclosed in the available information, so its mechanism of action is not described here.