Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
UCB |
---|---|
Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00263068 |
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 | Intervention | Phase |
---|---|---|
Restless Legs Syndrome |
Drug: Rotigotine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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 |
Enrollment: | 279 |
Study Start Date: | December 2005 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | UCB ( Study Director ) |
Study ID Numbers: | SP793 |
Study First Received: | December 5, 2005 |
Last Updated: | March 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00263068 History of Changes |
Health Authority: | United States: Food and Drug Administration |
IDIOPATHIC RESTLESS LEGS SYNDROME |
Neurotransmitter Agents Sleep Disorders Dyssomnias Psychomotor Agitation Dopamine Agonists Dyskinesias Sleep Disorders, Intrinsic Signs and Symptoms |
Dopamine Mental Disorders Restless Legs Syndrome Neurologic Manifestations Dopamine Agents Neurobehavioral Manifestations N 0437 |
Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Parasomnias Dyssomnias Sleep Disorders Psychomotor Agitation Dopamine Agonists Dyskinesias Pharmacologic Actions |
Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Mental Disorders Syndrome Restless Legs Syndrome Psychomotor Disorders Neurologic Manifestations Dopamine Agents Neurobehavioral Manifestations N 0437 |