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Sponsors and Collaborators: |
Medical College of Georgia GlaxoSmithKline |
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Information provided by: | Medical College of Georgia |
ClinicalTrials.gov Identifier: | NCT00344994 |
The purpose of this study is to determine the equipotent dose of ropinirole and pramipexole for patients switched from pramipexole to ropinirole in patients with moderate to severe primary Restless Legs Syndrome (RLS). The rationale behind Switch is that patients with Restless Legs Syndrome can maintain stable efficacy and tolerability if correctly switched from one dopamine agonist to an equipotent dose of another.
Condition | Intervention | Phase |
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Restless Legs Syndrome |
Drug: Mirapex(pramipexole) to Requip (Ropinirole) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study |
Official Title: | An Open-Label Prospective Study of Restless Legs Patients Switched to Ropinirole From Pramipexole to Help Determine the Equipotent Dose |
Estimated Enrollment: | 20 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | January 2008 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Anyone who does not fit the criteria stated under "Inclusion Criteria" and anyone who is included in the following criteria:
Contact: Kapil D Sethi, MD | 706-721-2798 | ksethi@mcg.edu |
Contact: John C Morgan, MD,PhD | 706-721-2798 | jmorgan@mcg.edu |
United States, Georgia | |
Medical College of Georgia | Recruiting |
Augusta, Georgia, United States, 30912 | |
Contact: Kapil D Sethi, MD 706-721-2798 ksethi@mcg.edu | |
Contact: John C Morgan, MD, PhD 706-721-2798 jmorgan@mcg.edu |
Principal Investigator: | Kapil D Sethi, MD | Medical College of Georgia |
Study ID Numbers: | gskswitch |
Study First Received: | June 23, 2006 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00344994 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Restless Legs Syndrome Mirapex (pramipexole) Requip(Ropinirole) Dopamine Agonist |
Ropinirole Ekbom syndrome Sleep Disorders Dyssomnias Psychomotor Agitation Dyskinesias Pramipexol |
Sleep Disorders, Intrinsic Signs and Symptoms Dopamine Mental Disorders Restless Legs Syndrome Neurologic Manifestations Neurobehavioral Manifestations |
Neurotransmitter Agents Disease Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Parasomnias Physiological Effects of Drugs Antiparkinson Agents |
Dopamine Agonists Protective Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Syndrome Psychomotor Disorders Dopamine Agents Central Nervous System Agents |