Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease
Information source: Colorado Neurology
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: Ropinirole Hydrochloride (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Agarwal, Pinky, M.D. Official(s) and/or principal investigator(s): Pinky Agarwal, MD, Principal Investigator, Affiliation: Colorado Neurology, P.C.
Overall contact: Deborah Judd, RN, CCRC, Phone: 303-762-6667, Email: judd@megapathdsl.net
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) would benefit from a higher dose of Requip as compared to the maximum
FDA approved dose of dopamine agonist drugs (including Requip, Mirapex, and Permax). Requip
as used in this study is investigational, which means it has not been approved by the US
Food and Drug Administration (FDA) at this dose level.
Clinical Details
Official title: Open Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's Disease
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Eligibility
Minimum age: 25 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Deborah Judd, RN, CCRC, Phone: 303-762-6667, Email: judd@megapathdsl.net
Colorado Neurology, P.C., Englewood, Colorado 80113, United States; Recruiting Deborah Judd, RN, CCRC, Phone: 303-762-6667, Email: judd@megapathdsl.net Pinky Agarwal, MD, Principal Investigator
Additional Information
Starting date: November 2005
Last updated: February 2, 2006
|