A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis

NCT01174004 | Completed Phase 3 Results

• 1 other identifier: ACP-103-020
• Study Type: interventional
• Target: 199
• Locations: 2 countries
• Sites: 63

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with Parkinson's disease psychosis (PDP).

Conditions

Parkinson's Disease Psychosis

Outcome Measures

Primary Outcomes (1)

• Antipsychotic Efficacy

  Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 43 in the Scale for the Assessment of Positive Symptoms 9-item sum score for Parkinson's Disease (SAPS-PD). The possible total score is 0 to 45 and a negative change in score indicates improvement. Analysis Method: Mixed Model Repeated Measures (MMRM)

  Each study visit (i.e. Days 1, 15, 29 and 43)

Secondary Outcomes (1)

• Motor Symptoms Change From Baseline (Negative = Improvement)

  Study Days 1 and 43

Study Arms (2)

1

EXPERIMENTAL

pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks

Drug: pimavanserin tartrate

2

PLACEBO COMPARATOR

placebo, tablet, once daily by mouth for 6 weeks

Drug: placebo

Interventions

pimavanserin tartrate DRUG

pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks

Also known as: ACP-103

1

placebo DRUG

placebo, tablet, once daily by mouth for 6 weeks

2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
• 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 Parkinson's disease diagnosis was established
• Subjects that are on anti-Parkinson's medication must be on a stable dose for 1 month prior to Study Day 1 (Baseline) and during the trial
• Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
• The subject is willing and able to provide consent
• Caregiver is willing and able to accompany the subject to all visits
• Subject and caregiver are willing and able to adequately communicate in English for the purposes of the primary assessment

You may not qualify if:

• Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
• Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
• Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
• Subject has had a myocardial infarction in last six months
• Subject has any surgery planned during the screening, treatment or follow-up periods
• Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (63)

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Gilbert, Arizona, 85234, United States

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Phoenix, Arizona, 85004, United States

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Phoenix, Arizona, 85013, United States

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Tucson, Arizona, 85724, United States

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Carson, California, 90746, United States

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Fountain Valley, California, 92708, United States

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Fresno, California, 93720, United States

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Fullerton, California, 92835, United States

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Irvine, California, 92697, United States

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La Habra, California, 90631, United States

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La Jolla, California, 92037, United States

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Loma Linda, California, 92354, United States

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Oxnard, California, 93030, United States

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Pasadena, California, 91105, United States

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Reseda, California, 91335, United States

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Sunnyvale, California, 94085, United States

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Ventura, California, 93003, United States

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Danbury, Connecticut, 06810, United States

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Boca Raton, Florida, 33486, United States

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Bradenton, Florida, 34205, United States

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Naples, Florida, 34102, United States

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Orlando, Florida, 32806, United States

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Ormond Beach, Florida, 32174, United States

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Panama City, Florida, 32405, United States

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Port Charlotte, Florida, 33980, United States

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St. Petersburg, Florida, 33713, United States

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Augusta, Georgia, 30912, United States

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Decatur, Georgia, 30033, United States

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Elk Grove Village, Illinois, 60007, United States

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Glenview, Illinois, 60026, United States

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Kansas City, Kansas, 66160, United States

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Louisville, Kentucky, 40202, United States

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Scarborough, Maine, 04074, United States

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Baltimore, Maryland, 21287, United States

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Boston, Massachusetts, 02215, United States

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Novi, Michigan, 48377, United States

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Roseville, Michigan, 48066, United States

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Traverse City, Michigan, 49684, United States

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Flowood, Mississippi, 39232, United States

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St Louis, Missouri, 63110, United States

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Missoula, Montana, 59802, United States

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Toms River, New Jersey, 08755, United States

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Albany, New York, 12208, United States

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Commack, New York, 11725, United States

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Kingston, New York, 12401, United States

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New York, New York, 10016, United States

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Durham, North Carolina, 27705, United States

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Raleigh, North Carolina, 27607, United States

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Salisbury, North Carolina, 28144, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43210, United States

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Toledo, Ohio, 43614, United States

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Greensburg, Pennsylvania, 15601, United States

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Providence, Rhode Island, 02906, United States

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Brentwood, Tennessee, 37027, United States

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Houston, Texas, 77030, United States

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Salt Lake City, Utah, 84108, United States

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Alexandria, Virginia, 22311, United States

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Roanoke, Virginia, 24018, United States

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Virginia Beach, Virginia, 23456, United States

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Milwaukee, Wisconsin, 53233, United States

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Ottawa, Ontario, K1G 4G3, Canada

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Related Publications (1)

• Cummings J, Isaacson S, Mills R, Williams H, Chi-Burris K, Corbett A, Dhall R, Ballard C. Pimavanserin for patients with Parkinson's disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet. 2014 Feb 8;383(9916):533-40. doi: 10.1016/S0140-6736(13)62106-6. Epub 2013 Nov 1.

  PMID: 24183563 DERIVED

MeSH Terms

Interventions

pimavanserin

Results Point of Contact

• Title: Roger Mills, MD
• Organization: ACADIA Pharmaceuticals Inc.

rmills@acadia-pharm.com

858-202-7563

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2010
• First Posted: August 3, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 26, 2014
• Results First Posted: March 26, 2014

Record last verified: 2014-02

Locations

US (62); CA (1)