An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Drug: Rotigotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic restless legs syndrome Exclusion Criteria: Subject has an ongoing serious adverse event from SP792 that is assessed to be related to the trial medication by the investigator and/or the sponsor. Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use 2 combined effective methods of contraception, including at least 1 barrier method, unless sexually abstinent. Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Up to 6.75 mg/day (optimal dosing) | Drug: Rotigotine<br>* Transdermal Patch 1 per day for 24 hours containing: 1.125mg/day 2.25mg/day 4.5mg/day 6.75mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability will be assessed by adverse events, changes in laboratory tests, changes in vital signs, physical and neurological examination, changes in menstrual and sexual function, global subject rating |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain data on changes in severity in RLS symptoms and quality of life over a one year maintenance period. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IDIOPATHIC RESTLESS LEGS SYNDROME