Restless Legs Syndrome Clinical Trial
Official title:
An Open-Label Extension Trial to Investigate the Safety and Tolerability of Long-Term Treatment With Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM
936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal
dose for up to 1 year. Subjects who successfully completed the Maintenance Period and the
Taper Period of SP792 are allowed to enroll in this trial.
All subjects will begin the Titration Period at a daily dosage of 1.125mg rotigotine (2.5cm2
patch). Subjects will be up-titrated at 7-day intervals in 1.125mg (2.5cm2 increments,
initial titration step only) and 2.25mg intervals (5cm2) increments to a maximum dose of
6.75mg/day (15cm2) rotigotine. The maximum length of titration is 28 days (±3 days),
although not all subjects will require 28 days to reach their optimal dose.
A subject's dose may be increased or decreased, as needed by the investigator to maintain a
subject's effective dose during the Maintenance Period. A Taper Period is provided to allow
for safe, gradual withdrawal from trial medication
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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