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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00329602 |
Purpose
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.
Eligibility| 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:
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.
Contacts and Locations
Hide Study Locations| Australia, New South Wales | |
| GSK Investigational Site | |
| Camperdown, New South Wales, Australia, 2050 | |
| Australia, Queensland | |
| GSK Investigational Site | |
| Kippa Ring, Queensland, Australia, 4021 | |
| Australia, South Australia | |
| GSK Investigational Site | |
| Woodville, South Australia, Australia, 5011 | |
| Australia, Victoria | |
| GSK Investigational Site | |
| Clayton, Victoria, Australia, 3168 | |
| GSK Investigational Site | |
| East Melbourne, Victoria, Australia, 3002 | |
| Czech Republic | |
| GSK Investigational Site | |
| Ostrava, Czech Republic, 702 00 | |
| GSK Investigational Site | |
| Pardubice, Czech Republic, 535 03 | |
| GSK Investigational Site | |
| Olomouc, Czech Republic, 775 20 | |
| GSK Investigational Site | |
| Praha 2, Czech Republic, 120 00 | |
| Denmark | |
| GSK Investigational Site | |
| Vejle, Denmark, 7100 | |
| GSK Investigational Site | |
| Aalborg, Denmark, 9000 | |
| GSK Investigational Site | |
| Odense C, Denmark, 5000 | |
| Germany | |
| GSK Investigational Site | |
| Berlin, Germany, 10787 | |
| GSK Investigational Site | |
| Berlin, Germany, 10969 | |
| Germany, Bayern | |
| GSK Investigational Site | |
| Regensburg, Bayern, Germany, 93053 | |
| GSK Investigational Site | |
| Bamberg, Bayern, Germany, 96047 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80331 | |
| Germany, Mecklenburg-Vorpommern | |
| GSK Investigational Site | |
| Schwerin, Mecklenburg-Vorpommern, Germany, 19053 | |
| Germany, Niedersachsen | |
| GSK Investigational Site | |
| Westerstede, Niedersachsen, Germany, 26655 | |
| Italy, Emilia-Romagna | |
| GSK Investigational Site | |
| Bologna, Emilia-Romagna, Italy, 40123 | |
| Italy, Lazio | |
| GSK Investigational Site | |
| Roma, Lazio, Italy, 00163 | |
| Italy, Lombardia | |
| GSK Investigational Site | |
| Pavia, Lombardia, Italy, 27100 | |
| Norway | |
| GSK Investigational Site | |
| Hamar, Norway, 2317 | |
| Portugal | |
| GSK Investigational Site | |
| Lisboa, Portugal, 1649-035 | |
| GSK Investigational Site | |
| Coimbra, Portugal, 3000-075 | |
| Slovakia | |
| GSK Investigational Site | |
| Zilina, Slovakia, 010 01 | |
| GSK Investigational Site | |
| Bratislava, Slovakia, 833 05 | |
| GSK Investigational Site | |
| Bratislava, Slovakia, 831 03 | |
| GSK Investigational Site | |
| Levoca, Slovakia, 054 01 | |
| GSK Investigational Site | |
| Dubnica nad Vahom, Slovakia, 018 41 | |
| Spain | |
| GSK Investigational Site | |
| San Sebastián, Spain, 20014 | |
| GSK Investigational Site | |
| Madrid, Spain, 28036 | |
| Sweden | |
| GSK Investigational Site | |
| AVESTA, Sweden, SE-774 82 | |
| GSK Investigational Site | |
| Örebro, Sweden, 701 85 | |
| GSK Investigational Site | |
| Göteborg, Sweden, SE-412 55 | |
| Switzerland | |
| GSK Investigational Site | |
| Zürich, Switzerland, 8091 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| 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 |
|
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 |