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| Sponsor: | 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 |
| 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 |
Hide Study Locations| United States, California | |
| Recruiting | |
| Reseda, California, United States | |
| Recruiting | |
| Ventura, California, United States, 93003 | |
| Recruiting | |
| Laguna HIlls, California, United States, 92653 | |
| Recruiting | |
| La Habra, California, United States, 90631 | |
| United States, Colorado | |
| Recruiting | |
| Englewood, Colorado, United States, 80113 | |
| United States, Connecticut | |
| Recruiting | |
| Farmington, Connecticut, United States, 06030 | |
| 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 | |
| Recruiting | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Recruiting | |
| Clinton Twp, Michigan, United States, 48035 | |
| Recruiting | |
| East lansing, Michigan, United States, 48824 | |
| Recruiting | |
| Detroit, Michigan, United States, 48201 | |
| 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 | |
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| Charlotte, North Carolina, United States, 28204 | |
| Recruiting | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Recruiting | |
| Toledo, Ohio, United States, 43614 | |
| United States, Pennsylvania | |
| Recruiting | |
| Philadelphia, Pennsylvania, United States, 19131 | |
| Recruiting | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| United States, Texas | |
| Recruiting | |
| Houston, Texas, United States, 77030 | |
| United States, Vermont | |
| Recruiting | |
| Burlington, Vermont, United States, 05401 | |
| Austria | |
| Recruiting | |
| Innsbruck, Austria, 6020 | |
| Belgium | |
| Recruiting | |
| Roeselare, Belgium, 8800 | |
| Recruiting | |
| Ottignies, Belgium, 1340 | |
| Recruiting | |
| Brussels, Belgium, 1090 | |
| Italy | |
| Recruiting | |
| Grossetto, Italy, 58100 | |
| Recruiting | |
| Chieti Scalo, Italy, 66013 | |
| Recruiting | |
| Roma, Italy, 00163 | |
| Recruiting | |
| Roma, Italy, 00185 | |
| Poland | |
| Recruiting | |
| Lublin, Poland, 20-090 | |
| Recruiting | |
| Lodz, Poland, 90-130 | |
| Recruiting | |
| Bydgoszcz, Poland, 85-096 | |
| Recruiting | |
| Katowice, Poland, 40-752 | |
| Portugal | |
| Recruiting | |
| Coimbra, Portugal, 3000-548 | |
| Recruiting | |
| Lisboa, Portugal, 1649-028 | |
| Recruiting | |
| Porto, Portugal, 4099-001 | |
| Serbia | |
| Recruiting | |
| Belgrade, Serbia, 11000 | |
| Spain | |
| Recruiting | |
| Barcelona, Spain, 08003 | |
| Recruiting | |
| Barcelona, Spain, 08195 | |
| Recruiting | |
| Barcelona, Spain, 08036 | |
| Recruiting | |
| Santiago De Compostela, Spain, 15706 | |
| Recruiting | |
| San Sebastian, Spain, 20009 | |
| Sweden | |
| Recruiting | |
| Stockholm, Sweden, SE-112 45 | |
| Recruiting | |
| Linkoping, Sweden, SE-581 85 | |
| Recruiting | |
| Jonkoping, Sweden, SE-551 85 | |
More Information
| Responsible Party: | ACADIA Pharmaceuticals Inc. ( Kimberly Wilson ) |
| Study ID Numbers: | ACP-103-014 |
| Study First Received: | April 10, 2008 |
| Last Updated: | July 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00658567 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Mental Disorders Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases Central Nervous System Diseases |
Psychotic Disorders Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases Schizophrenia and Disorders with Psychotic Features |