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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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12 December 2020 |
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Main ID: |
NCT00550238 |
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Date of registration:
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26/10/2007 |
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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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A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
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Scientific title:
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A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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459 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00550238 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Austria
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Belgium
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Canada
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France
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India
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Italy
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Poland
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Portugal
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Russian Federation
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Serbia
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Sweden
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Ukraine
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject has completed the treatment period of a previous blinded study of pimavanserin
- The subject is willing and able to provide consent
- Caregiver is willing and able to accompany the subject to all visits
Exclusion Criteria:
- Subject has current evidence of a serious and or unstable cardiovascular, respiratory,
gastrointestinal, renal, hematologic or other medical disorder
- Subject is judged by the Investigator to be inappropriate for the study
Age minimum:
40 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease Psychosis
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Intervention(s)
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Drug: Pimavanserin tartrate (ACP-103)
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Primary Outcome(s)
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Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
[Time Frame: From first to last study drug dose plus 30 days]
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Secondary ID(s)
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ACP-103-015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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