Status:
UNKNOWN
Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease
Lead Sponsor:
Agarwal, Pinky, M.D.
Collaborating Sponsors:
Colorado Neurology
GlaxoSmithKline
Conditions:
Parkinson's Disease
Eligibility:
All Genders
25+ years
Phase:
PHASE3
Brief Summary
The purpose of this research study is to see if subjects with Parkinson's disease who are experiencing motor fluctuations ("on" and "off" states) and dyskinesias (involuntary excessive movements) woul...
Eligibility Criteria
Inclusion
- Patients must give written informed consent prior to any specific study procedures.
- Males or females; females of childbearing age who are not currently pregnant must agree to use a medically accepted method of contraception throughout the study.
- Age greater than or equal to 25 years.
- Patients must be on a maximum dose of dopamine agonist drug (pergolide 4mg/day, pramipexole 4.5 mg/day or ropinirole 24mg/day).
- Stable dose of all medications for 4 weeks.
Exclusion
- Current hallucinations.
- History of disabling hallucinations or hallucinations in past requiring treatment.
- Troublesome edema (swelling).
- Unstable depression.
- Female who is pregnant or lactating.
- Use of an investigational drug with in the last 30 days.
- Other inclusion or exclusion criteria to be evaluated by the physician.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00260793
Start Date
November 1 2005
Last Update
February 3 2006
Active Locations (1)
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1
Colorado Neurology, P.C.
Englewood, Colorado, United States, 80113