NCT01976871

Switching From Oral Dopamine Agonists to Rotigotine

A Method to Switch From Oral Dopamine Agonists to Rotigotine in Patients With Restless Legs Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: John Winkelman, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Restless Legs Syndrome
• Ekbom Syndrome
• Willis-Ekbom Disease

Interventions

Type	Name	Description
DRUG	Rotigotine	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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-05-01
• Completion: 2015-12-01
• First posted: 2013-11-06
• Last updated: 2016-11-29
• Results posted: 2016-10-13

Locations

1 site across 1 country: United States