Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease

• Status: Completed
• Trial end date: 2008-07-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with Parkinson's Disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Piclozotan

Criteria

Main Inclusion Criteria:

• Idiopathic Parkinson's disease for at least 5 years

• Presence of motor fluctuations and dyskinesia

• Stable regimen of levodopa/carbidopa for 30 days

• At least 25% response/improvement in Unified Parkinson's Disease Rating Scale (UPDRS) part III scores after dosing with regular Parkinson's disease (PD) medications

• Mini-Mental State Examination (MMSE) score of 25 or higher

Main Exclusion Criteria:

• Atypical or secondary parkinsonism.

• Prior use of neuroleptic agents.

• History of intracranial procedures for PD.

• Active psychosis.

• History of drug or alcohol abuse in past 12 months.

• Cardiac conduction system abnormality.

• Predisposing medical condition that causes nausea or vomiting or routine use of an anti-emetic.