Parkinson's Disease
Conditions
Keywords
Ropinirole, Parkinson's disease, dopamine agonist
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) 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.
Interventions
Sponsors
Colorado Neurology
GlaxoSmithKline
Agarwal, Pinky, M.D.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Contacts
Primary ContactDeborah Judd, RN, CCRC
Outcome results
None listed