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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00530790 |
This study was designed to evaluate the safety, pharmacokinetic profile and efficacy in Restless Legs Syndrome patients.
Condition | Intervention | Phase |
---|---|---|
Restless Legs Syndrome (RLS) |
Drug: Ropinirole CR-RLS (SK&F106064) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | "Clinical Evaluation of Ropinirole CR-RLS Tablets in Restless Legs Syndrome -Open-Label, Uncontrolled Study- <Classification: Clinical Pharmacology, Exploratory> |
Estimated Enrollment: | 30 |
Study Start Date: | August 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At Week -1 (at the start of Screening period)
Gender: male and female Female of child-bearing potential will be eligible for inclusion in this study.However they have a negative pregnancy test at the screening visit. They agree to are performed pregnancy test at the time that is determined in Section ""6. Study Assessments and Procedures."" and practice one of the following method of contraceptions from the screening visit till the end of follow-up examination.
At Week 0 (at the start of treatment period)
Exclusion Criteria:
The severity refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences" (PAB/SD Notification No. 80, dated 29 June 1992).
Augmentation is defined as below:
Restless legs symptoms appear 2 hours earlier than the pre-treatment. Symptoms become severer than the pre-treatment. Symptoms which start after less time at rest than they did before treatment.. The restless legs symptoms extend to other sites (e.g. arm and trunk).
Japan | |
GSK Investigational Site | |
Osaka, Japan, 589-0022 | |
GSK Investigational Site | |
Fukuoka, Japan, 810-0044 | |
GSK Investigational Site | |
Fukuoka, Japan, 802-0084 | |
GSK Investigational Site | |
Tochigi, Japan, 321-0293 | |
GSK Investigational Site | |
Osaka, Japan, 550-0004 | |
GSK Investigational Site | |
Tokyo, Japan, 151-0053 | |
GSK Investigational Site | |
Tokyo, Japan, 187-0041 | |
GSK Investigational Site | |
Fukuoka, Japan, 830-0011 | |
GSK Investigational Site | |
Osaka, Japan, 599-8263 | |
GSK Investigational Site | |
Kanagawa, Japan, 210-0024 | |
GSK Investigational Site | |
Hiroshima, Japan, 733-0031 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 107846 |
Study First Received: | September 14, 2007 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00530790 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
RLS |
Ropinirole Ekbom syndrome Sleep Disorders Dyssomnias Psychomotor Agitation Dyskinesias Sleep Disorders, Intrinsic |
Signs and Symptoms Dopamine Mental Disorders Restless Legs Syndrome Neurologic Manifestations Neurobehavioral Manifestations |
Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Nervous System Diseases Parasomnias Antiparkinson Agents |
Dopamine Agonists Pharmacologic Actions Pathologic Processes Syndrome Therapeutic Uses Psychomotor Disorders Dopamine Agents Central Nervous System Agents |