Last reviewed · How we verify
A Method to Switch From Oral Dopamine Agonists to Rotigotine in Patients With Restless Legs Syndrome (SWITCH)
The primary objective is to demonstrate safety and tolerability of switching patients with Restless Legs Syndrome (RLS) from an oral dopamine agonist to rotigotine. As a secondary objective, the investigators will evaluate control of RLS symptoms on rotigotine compared to the prior oral regimen.
Details
| Lead sponsor | John Winkelman, MD, PhD |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 21 |
| Start date | 2014-08 |
| Completion | 2015-12 |
Conditions
- Restless Legs Syndrome
- Ekbom Syndrome
- Willis-Ekbom Disease
Interventions
- Rotigotine
Primary outcomes
- Proportion of Patients Completing the Switch and Their Adverse Events — Participants will be monitored for the duration of the study, approximately 6-10 weeks depending upon scheduling of visits
The primary endpoint will be the safety and tolerability of switching from an oral dopamine agonist to rotigotine. The CGIC scales were developed to assess treatment outcomes in pharmacological studies. The scales are meant completed by the clinician in person after assessment of the subject. They include 4 global scales describing the severity of illness, change in severity from baseline, therapeutic efficacy, and tolerability of treatment. Clinical Global Impression - Improvement scale (CGI-I) rated as: 1, very much improved since the baseline week; 2, much improved; 3, minimally improved; 4, no change from baseline; 5, minimally worse; 6, much worse; or 7, very much worse since the baseline week. The CGI-I was performed at baseline and at Week 5 to see which participants rated as much or very much improved. Adverse Events are reported in the Adverse Events module.
Countries
United States