drugset / Trial / NCT00991276
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
RandomizedCrossoverTriple-blindTreatment
Summary
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.
Timeline
- Start
- 2009-12
- Primary completion
- 2011-06
- Completion
- 2011-06
Outcome
Met primary endpoint
paper Pregabalin improved sleep maintenance, demonstrated by reductions in WASO (-27.1 min vs placebo [P < 0.0001]; PMID 24899755 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pramipexole | Unknown | 0.5 mg | — |
| Subject | Pregabalin | Small molecule | 300 mg | — |