A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's Disease
Status: Open to Enrollment
Start Date: Jul 01 2011
End Date: OPEN
Dr. David Shprecher at the University of Utah Department of Neurology is enrolling participants for the Double Blind, and Placebo-Controlled study of pimavanserin in patients with Parkinson’s Disease Psychosis (PDP). Pimavanserin is being developed by Acadia (the “Sponsor”), a pharmaceutical company based in the United States.The following are definitions pertaining to this study:
Randomized Trial: A research trial usually involves comparing different treatments. In a trial, one group will get one treatment and another group will get a different treatment. In a “randomized trial” people are put in one group or the other by random chance. This means that a computer will decide by chance which group a person is in, not the doctors running the trial.
Participants have a 1 in 2 (50%) chance of receiving pimavanserin (for example: for every two patients recruited, one will receive pimavansersin – and one patient will receive placebo).
Double Blind Trial: In this trial, neither you nor your doctor will know which treatment group you are in (although, if your doctor needs to find out for important medical reasons, he/she can do so) e.g. if you require emergency treatment.
Because we are testing the efficacy of pimavanserin we need to compare it to a placebo.
A placebo: is a dummy treatment such as a liquid which looks like the liquid that contains the study drug but it is not. Placebos contain no drugs or active ingredients. Study participants are given placebos so that the effects of a drug can be compared against no drug. Use of placebos also prevents the participant and the doctor from knowing whether or not the subject is getting the drug.
This study will determine:
- The antipsychotic efficacy of pimavanserin in subjects with PDP as measured by a decrease in the severity and/or frequency of hallucinations and/or delusions compared to a placebo.
- To demonstrate that pimavanserin does not worsen motor symptoms of PD in PDP subjects.
- To evaluate the effect of pimavanserin on global severity of psychosis and global improvement in psychosis in subjects with PDP.
- To demonstrate the safety and tolerability of pimavanserin.
- > 40 years of age
- > 1 year since diagnosis of Parkinson’s Disease
- Actively experiencing hallucinations and/or delusions related to PD
- > 1 month on a stable dose of anti-Parkinson’s medication
- No severe dementia present
B. Exclusion Criteria*:
- History of psychotic disorder not related to PD
- Diagnosis of atypical parkinsonism or dementia
- Ablative stereotaxic surgery
- Myocardial Infarcation within 6 months
C. Restricted Medications**:
*Please see protocol for complete list of inclusion/exclusion criteria and prohibited medications
**Please remember to contact your CRA or study staff member regarding any questionable medications
Michael Himle, PhD
Name: Maria North, Study Coordinator
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