• PDtrials - Parkinson's Disease Clinical Trials
• /Browse All Trials

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 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: NCT01174004
Study ID:

Summary

Parkinson’s disease psychosis (PDP), one of the most difficult non-motor symptoms  Non-Motor SymptomsContribute to severe disability and impaired quality of life in advanced Parkinson's disease. Symptoms include anxiety, depression, cognitive mood swings, dementia, constipation, pain, genitourinary problems, sudden drop in blood pressure upon standing (orthostatic hypotension), excessive sweating, and sleep disturbances, sense of smell, vision, memory, weight loss, psychosis, hallucinations, and loss of energy. of Parkinson’s to treat, manifests primarily as hallucinations  (seeing, feeling or hearing things that are not really there) and delusions (believing in something that is not true). There are no antipsychotic drugs approved in the United States to treat PDP. A study is currently being conducted to test a dose of 40 mg of an 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. called pimavanserin compared to 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.

Dose reduction of some PD medications may be attempted when psychotic symptoms first occur, but this often provides only modest benefit and usually results in increased motor dysfunction.  Off-label use of atypical antipsychotics may also be tried.  However, physicians are often reluctant to employ these drugs because they are associated with serious risks, including sedation, cardiovascular effects and impaired motor control.  Pimavanserin is different from other currently available antipsychotics because it principally acts on a single serotonin receptor subtype in the brain.  Through this selective receptor activity, pimavanserin is expected to improve psychosis (and possibly sleep) in people with PD without the side effect burden of other antipsychotic drugs. 

The study is similar to three previous trials of pimavanserin in which doses of 20 mg to 40 mg showed signals of antipsychotic effect without deleterious effects on motor function or other safety measures. The primary objective of the study is to demonstrate the antipsychotic efficacy of pimavanserin in people with PDP as measured by a decrease in the severity and/or frequency of hallucinations and/or delusions.  Other objectives are to demonstrate that pimavanserin does not worsen motor symptoms  Motor SymptomsThe physical symptoms of PD, such as balance, rigidity, tremor, freeze attacks, involuntary movements (dyskinesia), slowness of movement (bradykinesia), walking/gait, postural difficulties*, writing difficulty, swallowing difficulty* (dysphagia), muscle pain*, masked face*, speech problems* and general loss of motor skills. of PD, to evaluate the effect of pimavanserin on other measures of psychosis, sleep and burden on caregivers and to demonstrate the safety and tolerability of pimavanserin.

Upon completion of the six-week blinded study treatment period (in which neither the participant nor study staff will know whether active or placebo tablets are being administered), participants will have the option of rolling into a long-term extension study where they may receive 40 mg pimavanserin once daily for as long as it is of benefit to them.

Study Phase

Phase 3
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Psychosis, Hallucinations, Delusions

Time Commitment

• Less than six months
• One clinic visit will occur at the beginning of the two-week screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. period and will be followed by daily 10 to 30 minute activity sessions at home during this phase of the study. Additional clinic visits will occur every two weeks during the six-week treatment period. Four weeks after the end of treatment, participants will be asked to attend one additional follow-up visit at the clinic.

Eligibility

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

Inclusion Criteria

• Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
• Psychotic symptoms must have developed after PD diagnosis was established
• Person must be on stable dose of anti-Parkinson's medication for one month prior to Study Day 1 (Baseline)  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. and during the trial
• Person that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation  Deep Brain Stimulation (DBS)Procedure in which a small, surgically implanted, battery-operated medical device delivers electrical stimulation, and "turns-off" brain regions that produce Parkinson’s symptoms. must be at least six months post surgery and the stimulator settings must have been stable for at least one month prior to Study Day 1 (Baseline) and must remain stable during the trial
• The person is willing and able to provide consent
• Caregiver is willing and able to accompany the person to all visits

Exclusion Criteria

• Person has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of PD including, but not limited to, schizophrenia or bipolar disorder
• Person has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat PD
• Person has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal (kidney), hematologic (blood) or other medical disorder
• Person has had a heart attack (myocardial infarction) in last six months
• Person has any surgery planned during the screening, treatment or follow-up periods

Participants will be evaluated at screening to ensure that all criteria for study participation are met.

Enrollment

Expected Enrollment: 170 (US)
Date Enrollment Began: Jul 2010
Date Enrollment Ends: Jul 2012
Last Updated Date: Mar 14 2011
Trial Post Date: Jan 26 2011
Website: http://clinicaltrials.gov/show/NCT01174004

Primary Contacts and Locations

California

• Elizabeth Wood
  ACADIA Pharmaceuticals
  ewood@acadia-pharm.com
  Phone: (858) 202-7598
  3911 Sorrento Valley Blvd.
  San Diego, CA 92121
  USA
  
• Mary Hoskinson
  ACADIA Pharmaceuticals Inc.
  mhoskinson@acadia-pharm.com
  Phone: (858) 320-8620
  3911 Sorrento Valley Blvd.
  San Diego, CA 92121
  USA
  

View All Locations and Contacts