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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00243217 |
The objective of this trial is to demonstrate clinical efficacy of four different dosages of SPM 962 1.125 mg, 2.25 mg, 4.5 mg and 6.75 mg (corresponding to 2.5 cm2, 5 cm2, 10 cm2 and 15 cm2 patch size respectively) in RLS subjects. It is anticipated that rotigotine (SPM 936) will be more effective than placebo. The tolerability and safety of rotigotine will be assessed.
Condition | Intervention | Phase |
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Idiopathic Restless Leg Syndrome |
Drug: SPM 936 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Six-Arm, Parallel-Group, Dose-Finding Trial to Determine Efficacy, Safety and Tolerability of Five Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome |
Enrollment: | 341 |
Study Start Date: | April 2003 |
Study Completion Date: | February 2004 |
Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SP709 |
Study First Received: | October 20, 2005 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00243217 |
Health Authority: | United States: Food and Drug Administration |
Ekbom syndrome Sleep Disorders Dyssomnias Psychomotor Agitation Dyskinesias Sleep Disorders, Intrinsic Signs and Symptoms |
Dopamine Mental Disorders Restless Legs Syndrome Neurologic Manifestations Neurobehavioral Manifestations N 0437 |
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Parasomnias Nervous System Diseases Psychomotor Disorders Dopamine Agents Dopamine Agonists Pharmacologic Actions |