Status:
COMPLETED
Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease
Lead Sponsor:
Daiichi Sankyo
Conditions:
Parkinson's Disease
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with Parkinson's Disease.
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
July 13 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00623363
Start Date
July 13 2007
End Date
July 17 2008
Last Update
March 11 2021
Active Locations (7)
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1
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
2
University of South Florida, Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States, 33606
3
Emory University--Wesley Woods Health Center
Atlanta, Georgia, United States, 30329
4
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901