Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression

Completed · Phase 2

Conditions studied: Treatment of Depression in Adults With Parkinson's Disease (PD)

In brief

The purpose of this study is to assess the efficacy of pimavanserin for the treatment of depression in adults with Parkinson's disease.

Key facts

Study ID

NCT03482882

Run by

ACADIA Pharmaceuticals Inc.

People needed

47

Starts

2018-03-09

Expected to finish

2019-07-24

Last updated by the study team

2020-08-31

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Can understand and provide signed informed consent, request for medical records and/or subject privacy form if applicable according to local regulations
• Has a clinical diagnosis of idiopathic Parkinson's disease with a minimum duration of 1 year, defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features:
• rest tremor
• rigidity
• bradykinesia and/or akinesia
• postural and gait abnormalities
• Meets clinical criteria for depression with Parkinson's disease as listed in the NINDS/NIMH Guidelines
• If currently taking an anti-depressant, is being treated with only one SSRI or SNRI antidepressant at a dose within the US FDA-approved dose range. Subjects who are currently taking a second antidepressant or antidepressant augmentation agent at a sub-therapeutic dose or for an inadequate duration at Screening, and can be discontinued from this agent before the Baseline visit (in the opinion of the Investigator), may be eligible for the study.
• Is on a stable dose of anti-Parkinson's medication for 1 month prior to Screening
• If the subject is female, she must be of non-childbearing potential or agree to use two methods of clinically acceptable contraception

You may not qualify if…

• Use of an antipsychotic within 3 weeks or 5 half-lives of Baseline (whichever is longer)
• Had a myocardial infarction within the 6 months prior to Screening
• Has a known personal or family history or symptoms of long QT syndrome
• Evidence of severe or medically significant hepatic or renal impairment on laboratory tests as assessed by the Investigator or Medical Monitor
• Has a history of PD psychosis, schizophrenia, or other psychotic disorder, or bipolar I or II disorder.
• Actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
• Is pregnant or breastfeeding
• Has previously been treated with pimavanserin or is currently taking pimavanserin
• Has a sensitivity to pimavanserin or its excipients
• Is judged by the Investigator or the Medical Monitor to be inappropriate for the study
• Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Where it is running

• ATP Clinical Research, Inc. — Costa Mesa, California, United States
• The Parkinson's and Movement Disorder Institute — Fountain Valley, California, United States
• SC3 Research-Reseda — Pasadena, California, United States
• The Neurology Group — Pomona, California, United States
• SC3 Research-Reseda — Reseda, California, United States
• CNS Network — Torrance, California, United States
• Associated Neurologists, P.C. — Danbury, Connecticut, United States
• Parkinson's Disease and Movement Disorder Center of Boca Raton — Boca Raton, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Parkinson's Disease Treatment Center of SW Florida — Port Charlotte, Florida, United States
• Infinity Clinical Research, LLC — Sunrise, Florida, United States
• Tallahassee Neurological Clinic, P.A. — Tallahassee, Florida, United States
• SRI Biosciences, Clinical Trials and Strategic Development Services — Plymouth, Michigan, United States
• Washington University School of medicine — St Louis, Missouri, United States
• Bio Behavioral Health — Toms River, New Jersey, United States
• Albany Medical College — Albany, New York, United States
• David L. Kreitzman, MD, PC — Commack, New York, United States
• Asheville Neurology Specialists, PA — Asheville, North Carolina, United States
• Neurology/Neurophysiology — Johnstown, Pennsylvania, United States
• Booth Gardner Parkinson's Care Center — Kirkland, Washington, United States
• Inland Northwest Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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