A Study of Safety and Tolerability of Fipamezole in Adult Subjects With Parkinson's Disease Who Are Receiving Levodopa
The purpose of this clinical trial is to determine the maximum tolerated dose of Fipamezole in adult patients with Parkinson's disease who are receiving levodopa.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose-Escalation Study of Safety and Tolerability of Oromucosal Fipamezole ODT in Adult Subjects With Parkinson's Disease Who Are Receiving Levodopa|
- To determine the Maximum Tolerated Dose (MTD) of Fipamezole orally disintegrating tablets (ODT) in adult patients with Parkinson's disease. [ Time Frame: Days -28 to 56 ] [ Designated as safety issue: Yes ]
- To assess cardiovascular safety of ascending doses of Fipamezole ODT in adult patients with Parkinson's disease. [ Time Frame: Days -28 to 56 ] [ Designated as safety issue: Yes ]
- To evaluate pharmacokinetics (PK) of ascending doses of Fipamezole ODT in adult patients with Parkinson's disease. [ Time Frame: Days -28 to 56 ] [ Designated as safety issue: Yes ]
- To assess incidence and severity of Adverse Events [ Time Frame: Days -28 to 63 ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2010|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Drug: Fipamezole ODT
Subjects take three daily doses of Fipamezole ODT, with each dose escalating from 30 to 60, 90, 120, 150 and up to 180 mg over 8 weeks.
1 to 2 tablets three times per day to be taken according to the same schedule as the active study drug.
Parkinson's Disease is the second most common neurodegenerative disorder worldwide. While treatment with dopaminergic agents like levodopa, the mainstay of treatment, is effective in the early phases of the disease, their benefits decrease with disease progression, and problems such as dyskinesia and on-off phenomenon begin to manifest. In this study, fipamezole, a new antagonist of an adrenergic receptor, is being investigated to better understand the safety and side-effect profile in patients with Parkinson's Disease.
The sampling method used was simple random sampling.
|United States, California|
|CNS Network, Inc.|
|Torrance, California, United States, 90502|
|United States, Michigan|
|Quest Research Institute|
|Bingham Farms, Michigan, United States, 48025|
|United States, New Jersey|
|Clinical Research Integrity Worldwide LLC|
|Willingboro, New Jersey, United States, 08046|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Study Director:||Karen Briegs||Biovail Technologies, Ltd.|