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| Sponsor: | Medical College of Georgia |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Medical College of Georgia |
| ClinicalTrials.gov Identifier: | NCT00344994 |
Purpose
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 |
|---|---|---|
|
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 |
Show Detailed Description
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | gskswitch |
| Study First Received: | June 23, 2006 |
| Last Updated: | October 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00344994 History of Changes |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
Restless Legs Syndrome Mirapex (pramipexole) Requip(Ropinirole) Dopamine Agonist |
|
Neurotransmitter Agents Ropinirole Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Sleep Disorders Antiparkinson Agents Psychomotor Agitation Dopamine Agonists Pramipexol Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Mental Disorders |
Therapeutic Uses Syndrome Restless Legs Syndrome Psychomotor Disorders Neurobehavioral Manifestations Disease Parasomnias Nervous System Diseases Dyssomnias Dyskinesias Protective Agents Pharmacologic Actions Neurologic Manifestations Dopamine Agents Central Nervous System Agents |