NCT01149811

A Study Comparing the Safety and Tolerability of Two Doses of Fipamezole in Adult Patients With Parkinson's Disease

A Randomized, Double-Blind, Crossover Study Comparing the Safety and Tolerability of Two Dose Regimens of Oromucosal Fipamezole ODT in Adult Patients With Parkinson's Disease Who Are Receiving Levodopa

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (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 compare the safety and tolerability of two dose regimens 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. This study investigates the safety and tolerability of fipamezole at two dose levels 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 will receive fipamezole ODT 15 mg three times daily for 1 week followed by fipamezole ODT 30 mg three times daily for 1 week, followed by a 2-week washout period. Beginning at Visit 5, subjects will receive fipamezole ODT 30 mg three times daily for 2 weeks.
DRUG	Fipamezole ODT Cohort 2	Subjects will receive fipamezole ODT 30 mg three times daily for 2 weeks, followed by a 2-week washout period. Beginning at Visit 5, subjects will receive fipamezole ODT 15 mg three times daily for 1 week followed by fipamezole ODT 30 mg three times daily for 1 week.

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-06-24
• Last updated: 2012-06-22

Locations

4 sites across 1 country: United States