Switching From Oral Dopamine Agonists to Rotigotine
Condition: Restless Legs Syndrome; Ekbom Syndrome; Willis-Ekbom Disease
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Rotigotine
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Neupro
Intervention MeSH terms: Rotigotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Restless Legs Syndrome; Ekbom Syndrome; Willis-Ekbom Disease; Rotigotine; Neupro; Dopamine Agonist