Switching From Oral Dopamine Agonists to Rotigotine (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.
Restless Legs Syndrome
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Method to Switch From Oral Dopamine Agonists to Rotigotine in Patients With Restless Legs Syndrome|
- Proportion of patients completing the switch and their adverse events [ Time Frame: Participants will be monitored for the duration of the study, approximately 6-10 weeks depending upon scheduling of visits ] [ Designated as safety issue: Yes ]The primary endpoint will be the tolerability of switching from an oral dopamine agonist to rotigotine.
- International Restless Legs Scale (IRLS) [ Time Frame: Study Visit 3 (approximately 28 days after the last dose of oral dopamine agonist) ] [ Designated as safety issue: No ]The IRLS will be used to determine the overall efficacy of RLS symptom control on rotigotine
- RLS-6 Scales [ Time Frame: Average of Baseline week (approximately days 1-7 of the study) vs. Average of Final Treatment week (approximately days 21-28 of the maintenance period) ] [ Designated as safety issue: No ]The RLS-6 scales will be used to determine the overall efficacy of RLS symptom control on rotigotine, calculated as a mean score for each scale during the final treatment week vs baseline.
- Preference of Medication Scale (POM) [ Time Frame: Study visit 3 (approximately 28 days after the last dose of oral dopamine agonist) ] [ Designated as safety issue: No ]The POM will be used to assess patient satisfaction with treatment
- The Patient Global Impression of Change scale [ Time Frame: Study visit 3 (approximately 28 days after the last dose of oral dopamine agonist) ] [ Designated as safety issue: No ]The Patient Global Impression of Change scale (PGIC) will be used to assess patient satisfaction with treatment.
- The Clinician Global Impression of Change Scale [ Time Frame: Study visit 3 (approximately 28 days after the last dose of oral dopamine agonist) ] [ Designated as safety issue: No ]The Clinician Global Impression of Change scale (CGIC) will be used to assess patient satisfaction with treatment.
|Study Start Date:||August 2014|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Oral Dopamine Agonist to Rotigotine
During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.
Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator.
Other Name: Neupro
The study will consist of 3 in-person visits and 4 scheduled telephone appointments over the course of approximately 6 weeks. The first visit will be the screening visit during which eligibility will be confirmed and informed consent obtained. After the first visit, subjects will continue their current oral dopamine agonist for a one-week baseline period during which they will record RLS symptoms daily.
The second visit will be the baseline visit. The IRLS scale, a commonly used measure of RLS symptoms, will be obtained. An individualized schedule for down-titration of oral dopamine agonist and concomitant up-titration of rotigotine will be provided. After the second visit, subjects will begin this cross-titration. This will entail a pre-determined incremental taper of the oral medication and flexible up-titration of rotigotine according to symptoms. During this time, subjects will keep diaries of RLS symptoms and will speak with the investigator over the phone a total of 3 times (visits 2a-2c) to discuss dosing of rotigotine.
After the titration is complete, subjects will enter the maintenance period, which will last 28 days. There will be another phone contact (2d) one week after the titration is complete to adjust the dose of rotigotine as needed. The subject will then continue the chosen dose for the next 3 weeks of the maintenance period. There will be one final phone contact (2e) 1 week prior to the end of the maintenance period to remind subjects to resume RLS symptom diaries during the final week of the maintenance period.
The third and final visit will take place at the end of the maintenance period. RLS symptoms will be discussed and the IRLS scale, Clinician Global Impression of Change (CGIC), Patient Global Impression of Change (PGIC), and Preference of Medication Scale (POMS) will be administered.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01976871
|Contact: John W. Winkelman, MD, PhD||617-643-9101||JWWINKELMAN@PARTNERS.ORG|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: John W. Winkelman, MD, PhD JWWINKELMAN@PARTNERS.ORG|
|Principal Investigator: John W. Winkelman, MD, PhD|