NCT01140841

A Study of Safety and Tolerability of Fipamezole in Adult Subjects With Parkinson's Disease Who Are Receiving Levodopa

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
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.
DRUG	Placebo	1 to 2 tablets three times per day to be taken according to the same schedule as the active study drug.

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-06-10
• Last updated: 2011-08-31

Locations

4 sites across 1 country: United States