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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00623363 |
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Date of registration:
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02/01/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease
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Scientific title:
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Date of first enrolment:
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April 2007 |
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Target sample size:
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27 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00623363 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Guatemala
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Romania
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United States
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: piclozotan
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Drug: 0.9% sodium chloride (normal saline)
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Primary Outcome(s)
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"on" time without dyskinesia
[Time Frame: 48 hours]
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Secondary Outcome(s)
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pharmacokinetic data for investigational study drug
[Time Frame: 48 hours]
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Safety and tolerability data as measured by adverse events, electrocardiograms, physical exams, clinical laboratories tests, and vital signs
[Time Frame: 48 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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