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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00329602 |
This is an initial placebo-controlled study followed by open treatment evaluating the effectiveness and tolerability of ropinirole long-term in patients with moderate to severe Restless Legs Syndrome.
Condition | Intervention | Phase |
---|---|---|
Restless Legs Syndrome (RLS) |
Drug: Ropinirole oral tablets |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | See Detailed Description |
Estimated Enrollment: | 400 |
Study Start Date: | March 2006 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open-label extension treatment period in subjects suffering from moderate to severe Restless Legs Syndrome.
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A female is eligible to enter and participate in the study if she is of:
Childbearing potential, has a negative result on all required pregnancy tests prior to randomisation, and agrees to an acceptable contraceptive method as defined in Appendix 3.
Exclusion criteria:
These medications include the following:
Atypical and typical antipsychotics, anticonvulsants, opioids (including propoxyphene and oxycodone), anxiolytics, all sedatives/hypnotics (including benzodiazepines), lithium, oral neuroleptics, stimulants (including methylphenidate), dopamine agonists (including ropinirole), dopamine antagonists (e.g., typical neuroleptics, metoclopramide), levodopa/carbidopa, clonidine, and sedating antihistamines (e.g., chlorpheniramine, diphenhydramine, hydroxyzine) or any preparations containing these antihistamines. The minimum discontinuation period is generally 5 half lives or 7 consecutive evenings/nights medication free, prior to baseline, whichever is the longer period. Exceptions to this general rule are: fluoxetine, monoamine oxidase inhibitors: 4 weeks.
For subjects entering the 40-week, open-label treatment phase, the GSK Medical Monitor can be contacted to discuss individual cases where adherence to the above may not have occurred.
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | ROR104836 |
Study First Received: | May 23, 2006 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00329602 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Moderate Severe Restless Legs Syndrome ropinirole |
Neurotransmitter Agents Ropinirole 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 |
Ropinirole Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Sleep Disorders Antiparkinson Agents Psychomotor Agitation Dopamine Agonists Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Mental Disorders Syndrome |
Therapeutic Uses Restless Legs Syndrome Psychomotor Disorders Neurobehavioral Manifestations Disease Parasomnias Nervous System Diseases Dyssomnias Dyskinesias Pharmacologic Actions Neurologic Manifestations Dopamine Agents Central Nervous System Agents |