|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Georgia Health Sciences University |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Georgia Health Sciences University |
| 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: pramipexole |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
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| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| Principal Investigator: | Kapil D Sethi, MD | Georgia Health Sciences University |
More Information
| Responsible Party: | Dr. Kapil Sethi/ / PI, Georgia Health Sciences University |
| ClinicalTrials.gov Identifier: | NCT00344994 History of Changes |
| Other Study ID Numbers: | gskswitch |
| Study First Received: | June 23, 2006 |
| Last Updated: | May 12, 2011 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
Restless Legs Syndrome Mirapex (pramipexole) Requip(Ropinirole) Dopamine Agonist |
|
Restless Legs Syndrome Psychomotor Agitation Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Parasomnias Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms Pramipexol |
Ropinirole Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agonists Dopamine Agents Neurotransmitter Agents |