Status:
COMPLETED
SWITCH:Restless Legs Patients Switched to Ropinirole From Pramipexole
Lead Sponsor:
Augusta University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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 Le...
Detailed Description
BACKGROUND Dopamine agonists such as ropinirole (Requip) and pramipexole (Mirapex) are effective treatments for Restless Legs Syndrome and Parkinson Disease. However, although the safety and efficacy ...
Eligibility Criteria
Inclusion
- Written informed consent is obtained
- Males and/or females; females of childbearing potential, who are not currently pregnant, must agree to use a medically accepted method of contraception throughout the study (i.e., oral contraception, intra- uterine device, or a long-acting injectable form of contraception). Barrier methods alone (i.e., condom) are not adequate.
- Age \> 18 years to ≤ 80 years
- Patients with moderate to severe primary RLS
- Stable dose of Pramipexole, between 0.25 mg and 0.75mg, for Restless Legs Syndrome for 4 weeks prior to enrollment
- IRLS \>15 (before pramipexole was initiated)
Exclusion
- Anyone who does not fit the criteria stated under "Inclusion Criteria" and anyone who is included in the following criteria:
- Currently taking neuroleptic medications
- Currently taking dopamine blocking anti-emetic medications.
- Currently taking any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, fluvoxamine) or induce CYP1A2 (e.g., omeprazole) (Note: Subjects already on these agents may be enrolled, but must remain on stable doses of the agents from (Visit 1) 14 days prior to Baseline to the end of the study.
- Current hallucinations
- History of disabling hallucinations or hallucinations in past requiring treatment
- Mini-Mental status examination score \< 25 on a scale of 30
- Orthostatic hypotension \>30 systolic drop and \>20 diastolic drop
- On cholinesterase inhibitors or memantine
- Troublesome edema due to any reason
- Epworth sleepiness scale \>8
- Another primary sleep disorder (e.g. obstructive sleep apnea, narcolepsy)
- Secondary causes of RLS (iron deficiency, renal failure)
- Unstable medical conditions as determined by the investigator
- Inadequately managed depression (patient on antidepressants must be on stable dose for 4 weeks prior to enrollment)
- Other stable medical conditions which may interfere with patient evaluation
- Female who is pregnant or lactating
- Use of an investigational drug within the last 30 days
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00344994
Start Date
May 1 2006
End Date
April 1 2010
Last Update
May 13 2011
Active Locations (1)
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1
Medical College of Georgia
Augusta, Georgia, United States, 30912