Clinical Trials

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

Description

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:

  1. 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.
  2. To demonstrate that pimavanserin does not worsen motor symptoms of PD in PDP subjects.
  3. To evaluate the effect of pimavanserin on global severity of psychosis and global improvement in psychosis in subjects with PDP.
  4. To demonstrate the safety and tolerability of pimavanserin.
A. Inclusion Criteria*:
  • > 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**:

  • Antipsychotics
  • Antiarrythmics
  • Anticonvulsants
  • Antidepressants
  • Antihistamines
  • Antimicrobials

*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

Principal Investigators

David Shprecher, D.O.

Co Investigators

Lauren Schrock, M.D.

Michael Himle, PhD

Contact Information

Name: Maria North, Study Coordinator
Phone: 801-581-7978
Email: maria.north@hsc.utah.edu

Please Note:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician, we can help you find a University of Utah doctor or clinic location to meet your health care needs.

Although the studies described on this Web site may have potential benefits as described, the University of Utah and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study.

The information posted on this site is consistent with the research reviewed and approved by the University of Utah Institutional Review Board (IRB). However, the IRB has not reviewed all material posted on this site. Contact the IRB if you have questions regarding your rights as a research participant. Also contact the IRB if you have questions, complaint, or concerns which you do not feel you can discuss with the investigator. The University of Utah IRB may be reached by phone at (801) 581-3655 or by e-mail at irb@hsc.utah.edu.