Back to resultsAripiprazole in Patients With Psychosis Associated With Parkinson's Disease
Primary Purpose
Parkinson's Disease, Psychoses
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Psychosis, Parkinson's Disease
Eligibility Criteria
Inclusion Criteria: Primary diagnosis of idiopathic Parkinson's disease. Psychosis related to Parkinson's disease. Exclusion Criteria: Psychosis present prior to diagnosis of Parkinson's disease.
Sites / Locations
- Local Institution
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Tolerability
Secondary Outcome Measures
Safety Assessments
Full Information
NCT ID
NCT00095810
First Posted
November 9, 2004
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00095810
Brief Title
Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease
Official Title
An Open-Label Study of Aripiprazole to Evaluate the Safety and Tolerability in Patients With Psychosis Associated With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
The purpose of this clinical research study is to assess the safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Psychoses
Keywords
Psychosis, Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, Oral, 1-10mg, Once daily, 6 weeks.
Primary Outcome Measure Information:
Title
Tolerability
Secondary Outcome Measure Information:
Title
Safety Assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary diagnosis of idiopathic Parkinson's disease.
Psychosis related to Parkinson's disease.
Exclusion Criteria:
Psychosis present prior to diagnosis of Parkinson's disease.
Facility Information:
Facility Name
Local Institution
City
Albany
State/Province
New York
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17013906
Citation
Friedman JH, Berman RM, Goetz CG, Factor SA, Ondo WG, Wojcieszek J, Carson WH, Marcus RN. Open-label flexible-dose pilot study to evaluate the safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease. Mov Disord. 2006 Dec;21(12):2078-81. doi: 10.1002/mds.21091.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/17013906?dopt=Abstract
Description
PhRMA website-CSR Synopsis
Learn more about this trial
Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease
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