Long-term Study Of Ropinirole In Restless Legs Syndrome
Summary
This is an initial placebo-controlled study followed by open treatment evaluating the effectiveness and tolerability of ropinirole long-term in patients with moderate to severe Restless Legs Syndrome.
Timeline
- Start
- 2006-03
- Primary completion
- 2008-09
- Completion
- 2008-09
Outcome
Met primary endpoint
paper Ropinirole was significantly better than placebo for change from baseline in the IRLS total score during both short- and long-term treatment PMID 23938061 ↗
registry analysis (superiority or other test); Double-blind Placebo vs Double-blind Ropinirole IR; p = 0.039; Repeated Measures Mixed Model; note: P-value is for Week 12. NCT00329602 ↗
registry analysis (superiority or other test); Double-blind Placebo vs Double-blind Ropinirole IR; p = 0.023; Repeated Measures Mixed Model; note: P-value is for Week 26. NCT00329602 ↗
Publications
- Background Garcia-Borreguero D, Hogl B, Ferini-Strambi L, Winkelman J, Hill-Zabala C, Asgharian A, Allen R. Systematic evaluation of augmentation during treatment with ropinirole in restless legs syndrome (Willis-Ekbom disease): results from a prospective, multicenter study over 66 weeks. Mov Disord. 2012 Feb;27(2):277-83. doi: 10.1002/mds.24889. Epub 2012 Jan 4.
- Giorgi L, Asgharian A, Hunter B. Ropinirole in patients with restless legs syndrome and baseline IRLS total scores >/= 24: efficacy and tolerability in a 26-week, double-blind, parallel-group, placebo-controlled study followed by a 40-week open-label extension. Clin Ther. 2013 Sep;35(9):1321-36. doi: 10.1016/j.clinthera.2013.06.016. Epub 2013 Aug 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ropinirole | Small molecule | 0.25 mg | — |
| Subject | Ropinirole | Small molecule | 4 mg | — |