A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
Tracking Information
Start Date ICMJE | July 2007 |
---|---|
Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 21, 2007) | Safety [ Time Frame: Duration of the treatment period ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00550238 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 21, 2007) | Safety [ Time Frame: Duration of the treatment period ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis |
---|---|
Official Title ICMJE | 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 |
Brief Summary | To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Condition ICMJE | Parkinson's Disease Psychosis |
Intervention ICMJE | Drug: pimavanserin tartrate (ACP-103) tablets once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects |
Recruitment Information
Estimated Enrollment ICMJE | 500 | ||||
---|---|---|---|---|---|
Completion Date | |||||
Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Gender | Both | ||||
Ages | 40 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
| ||||
Location Countries ICMJE | United States, Russian Federation, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00550238 |
---|---|
Responsible Party | Kimberly Wilson, ACADIA Pharmaceuticals Inc. |
Study ID Numbers ICMJE | ACP-103-015 |
Study Sponsor ICMJE | ACADIA Pharmaceuticals Inc. |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | ACADIA Pharmaceuticals Inc. |
Source: http://clinicaltrials.gov/