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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00623363
Date of registration: 02/01/2008
Prospective Registration: No
Primary sponsor: Asubio Pharmaceuticals, Inc.
Public title: Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease
Scientific title:
Date of first enrolment: April 2007
Target sample size: 27
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00623363
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Guatemala Romania United States
Contacts
Key inclusion & exclusion 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 UPDRS part III scores after dosing with regular
PD medications

- 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.



Age minimum: 40 Years
Age maximum: 85 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Parkinson's Disease
Intervention(s)
Drug: 0.9% sodium chloride (normal saline)
Drug: piclozotan
Primary Outcome(s)
"on" time without dyskinesia [Time Frame: 48 hours]
Secondary Outcome(s)
pharmacokinetic data for investigational study drug [Time Frame: 48 hours]
Safety and tolerability data as measured by adverse events, electrocardiograms, physical exams, clinical laboratories tests, and vital signs [Time Frame: 48 hours]
Secondary ID(s)
ASBI-501
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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