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Tracking Information | |
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First Received Date ICMJE | July 9, 2004 |
Last Updated Date | December 5, 2005 |
Start Date ICMJE | March 2004 |
Current Primary Outcome Measures ICMJE |
ACP-103 is an effective treatment for Parkinson's Disease with psychosis |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00087542 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
ACP-103 does not cause worsening of motor function in Parkinson's Disease |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information | |
Brief Title ICMJE | Treatment of Hallucinosis/Psychosis in Parkinson's Disease by an Investigational Drug |
Official Title ICMJE | |
Brief Summary | The primary objective is to demonstrate that the investigational new drug, ACP-103, is well tolerated by, and will not worsen parkinsonism in, patients with Parkinson's disease and psychosis. The secondary objectives are to determine whether ACP-103 will ameliorate psychosis in patients with Parkinson's disease and whether ACP-103 is safe in Parkinson's disease patients taking multiple anti-parkinsonian medications. |
Detailed Description | This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial of four weeks of ACP-103 treatment of psychosis in Parkinson's disease, with four weeks follow-up. A total of 60 patients meeting entrance criteria will be randomly assigned to receive placebo (30 patients) or active drug (30 patients). Subjects will take study drug daily starting on Day 1. Dose escalations can occur on Study Days 8 and 15 only, and patients will receive a stable daily dosage from Day 16 until Day 28. Single step dose reductions are allowed during that period for adverse events or intolerance. Patients will be evaluated at screening/baseline and at Study Days 1, 8, 15, 28, and 57 by raters blinded to the treatment. The major response variable will be motoric tolerability. Secondary response variables will be efficacy against psychosis and safety. Currently, there are no approved drugs for this indication in the United States. Psychotic symptoms in Parkinson's disease patients are almost always stable, often non-threatening, and rarely paranoid or violent in content. The trial includes the requirement that each patient enrolled has a reliable caretaker who will accompany the patient to each visit who can reliably report on the patient's daily level of function. These factors argue for the safe inclusion of a four-week period of placebo treatment. |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study |
Condition ICMJE |
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Intervention ICMJE | Drug: ACP-103 |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 60 |
Completion Date | December 2005 |
Primary Completion Date | |
Eligibility Criteria ICMJE | Inclusion Criteria Male and female patients of any ethnic group and of any age are eligible for participation in this study, providing they meet all the following criteria:
Exclusion Criteria Patients who meet any of the following conditions are excluded from the clinical study:
Quetiapine and clozapine-treated patients may be enrolled if these agents were discontinued due to drug intolerability. Such patients must not have taken these drugs within the past two weeks.
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Gender | Both |
Ages | |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID ICMJE | NCT00087542 |
Responsible Party | |
Study ID Numbers ICMJE | ACP-103-006 |
Study Sponsor ICMJE | ACADIA Pharmaceuticals Inc. |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | ACADIA Pharmaceuticals Inc. |
Verification Date | December 2005 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |