Restless Legs Syndrome Clinical Trial
Official title:
A Method to Switch From Oral Dopamine Agonists to Rotigotine in Patients With Restless Legs Syndrome
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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