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Official Study Title: A Multi-Center, Placebo-Controlled, Double-Blind  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. Trial to Examine the Safety and Efficacy  EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. of ACP-103(Pimavanserin) in the Treatment of Psychosis  PsychosisA loss of contact with reality often accompanied by hallucinations. Psychosis can be caused by some PD medications and is more common in patients with advanced Parkinson's. in Parkinson's Disease
Sponsor: ACADIA Pharmaceuticals Inc.
Clinicaltrials.gov ID: NCT00477672
Study ID: ACP-103-012

Summary

Studies have suggested that up to 40 percent of people with Parkinson's disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD) will develop psychotic symptoms, commonly consisting of visual hallucinations and delusions. The development of psychosis in people with PD is a major event in the clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. progression of this disease. It disrupts their ability to perform many of the activities of daily living that keep them independent and active. As a result, PD psychosis is the most common factor leading to nursing home placements of people with PD. The purpose of this research study is to evaluate the safety and efficacy of a new investigational drug,  Investigational DrugDrug that is being tested in clinical trials prior to receiving FDA approval for use on the open market or as a treatment for a particular condition. pimavanserin (ACP-103), in participants with PD-related psychosis. Eligible participants will be evaluated at screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. to ensure that all criteria for study participation are met. These evaluations will include determination of the presence of hallucinations or delusions, memory loss, and general health of the participant. People may be excluded from the study based on the presence or absence of symptoms and medical conditions identified in this screening assessment. Participants selected for the study will be randomly assigned (flip of the coin), to either one of two doses of pimavanserin or placebo  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. (an inactive look-alike pill) and will take the study drug once daily by mouth for six weeks and then will be followed for an additional four weeks. Participants and their caregivers return to the clinic six times for both efficacy and safety evaluations. Two hundred and eighty participants are to be enrolled in 50 sites across the U.S. and Europe. The total duration of participation is approximately 13 weeks. An open label extension study in which all participants receive pimavanserin is available for those participants who complete the study and qualify. Please contact the Project Manager for information on a study doctor in your area. Below is a list of cities in which the study is being conducted. Please check back as new sites are being activated.

Study Phase

Phase 3
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Psychosis

Time Commitment

• Less than six months
• Weekly through Day 15 and then biweekly.

Eligibility

• Minimum Age: 40
• Gender(s) Accepted: Either
• Minimum Years Since Diagnosis: 1

Inclusion Criteria

• Either male or female
• Age 40 and above
• Established diagnosis of PD for at least 1 year
• Experiencing visual or auditory hallucinations and/or delusions for at least 1 month
• Willing and able to attend and participate in all study visits, with a caregiver if necessary

Enrollment

Expected Enrollment: 280 (US)
Date Enrollment Began: Jun 01 2007
Last Updated Date: Jan 16 2008
Trial Post Date: Jan 16 2008
Website: http://clinicaltrials.gov/ct2/show/NCT00477672?term=NCT00477672&rank=1

Primary Contacts and Locations

All States

• Kimberly Wilson — Project Manager
  ACP-103clintrials@acadia-pharm.com
  Phone: 858-320-8678
  All States
  USA
  

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