MedTrace Logo

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

NCT01149811 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 27

Last updated 2012-06-22

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Ralph T. Doyle · Bausch Health Americas, Inc.

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01149811 on ClinicalTrials.gov