An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Up to 6.75 mg/day (optimal dosing) |
Drug: Rotigotine
Transdermal Patch 1 per day for 24 hours containing:
1.125mg/day 2.25mg/day 4.5mg/day 6.75mg/day
|
Outcome Measures
Primary Outcome Measures
- 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
- To obtain data on changes in severity in RLS symptoms and quality of life over a one year maintenance period. [1 year]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Schwarz | RTP | North Carolina | United States |
Sponsors and Collaborators
- UCB Pharma
Investigators
- Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SP0793