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| Sponsored by: |
ACADIA Pharmaceuticals Inc. |
| Information provided by: | ACADIA Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00658567 |
Purpose
This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.
| Condition | Intervention | Phase |
|
Parkinson's Disease Psychosis |
Drug: Pimavanserin tartrate (ACP-103) |
Phase III |
| Genetics Home Reference related topics: | familial paroxysmal nonkinesigenic dyskinesia Parkinson disease |
| MedlinePlus related topics: | Parkinson's Disease Psychotic Disorders |
| ChemIDplus related topics: | ACP 103 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Estimated Enrollment: | 240 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
2: Experimental
pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
|
Drug: Pimavanserin tartrate (ACP-103)
20 mg, tablet, once daily by mouth, for six weeks
|
|
3: Placebo Comparator
Placebo tablet, once daily by mouth, 6 weeks
|
Drug: Pimavanserin tartrate (ACP-103)
Placebo, tablet, once daily by mouth, for six weeks
|
|
1: Experimental
pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
|
Drug: Pimavanserin tartrate (ACP-103)
10 mg, tablet, once daily by mouth, for six weeks
|
Eligibility
| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).
Contacts and Locations| Contact: Kimberly Wilson | ACP-103clintrials@acadia-pharm.com |
| United States, California | |||||
| Recruiting | |||||
| Reseda, California, United States | |||||
| Recruiting | |||||
| Ventura, California, United States, 93003 | |||||
| Recruiting | |||||
| Laguna HIlls, California, United States, 92653 | |||||
| United States, Colorado | |||||
| Recruiting | |||||
| Englewood, Colorado, United States, 80113 | |||||
| United States, Florida | |||||
| Recruiting | |||||
| Sarasota, Florida, United States, 34233 | |||||
| Recruiting | |||||
| Deerfield Beach, Florida, United States, 33064 | |||||
| Recruiting | |||||
| Panama City, Florida, United States, 32405 | |||||
| United States, Massachusetts | |||||
| Recruiting | |||||
| Boston, Massachusetts, United States, 02215 | |||||
| United States, Michigan | |||||
| Recruiting | |||||
| Clinton Twp, Michigan, United States, 48035 | |||||
| Recruiting | |||||
| East lansing, Michigan, United States, 48824 | |||||
| United States, Missouri | |||||
| Recruiting | |||||
| Columbia, Missouri, United States, 65201 | |||||
| United States, Nebraska | |||||
| Recruiting | |||||
| Omaha, Nebraska, United States, 68131 | |||||
| United States, New York | |||||
| Recruiting | |||||
| Albany, New York, United States, 12208 | |||||
| Recruiting | |||||
| Commack, New York, United States, 11725 | |||||
| United States, North Carolina | |||||
| Recruiting | |||||
| New Bern, North Carolina, United States | |||||
| Recruiting | |||||
| Charlotte, North Carolina, United States, 28204 | |||||
| Austria | |||||
| Recruiting | |||||
| Innsbruck, Austria, 6020 | |||||
| Poland | |||||
| Recruiting | |||||
| Lublin, Poland, 20-090 | |||||
| Recruiting | |||||
| Lodz, Poland, 90-130 | |||||
| Recruiting | |||||
| Bydgoszcz, Poland, 85-796 | |||||
| Spain | |||||
| Recruiting | |||||
| Barcelona, Spain, 08003 | |||||
| ACADIA Pharmaceuticals Inc. |
More Information
| Responsible Party: | ACADIA Pharmaceuticals Inc. ( Kimberly Wilson ) |
| Study ID Numbers: | ACP-103-014 |
| First Received: | April 10, 2008 |
| Last Updated: | September 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00658567 |
| Health Authority: | United States: Food and Drug Administration |
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