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

NCT03482882 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ACP-103-048
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 21

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 8 in HAMD-17 (Hamilton Depression Scale -17 Items) Total Score

  The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe depression.

  From baseline to Week 8

Secondary Outcomes (7)

• Change From Baseline (CFB) in HAMD-17 Total Score at Weeks 2, 4, and 6

  2, 4, and 6 weeks from baseline

• Clinical Global Impression-Improvement (CGI-I)

  At Week 8

• Change From Baseline (CFB) in Clinical Global Impression-Severity (CGI-S)

  From baseline to Week 8

• Change From Baseline (CFB) in Scale of Outcomes in PD-Sleep Scale (SCOPA) Nighttime Sleep (NS)Score

  From baseline to Week 8

• Change From Baseline (CFB) in SCOPA Daytime Sleepiness (DS) Score

  From baseline to Week 8

Study Arms (1)

Drug - pimavanserin

EXPERIMENTAL

Drug: Pimavanserin

Interventions

Pimavanserin DRUG

Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)

Drug - pimavanserin

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (21)

ATP Clinical Research, Inc.

Costa Mesa, California, 92626, United States

Location

The Parkinson's and Movement Disorder Institute

Fountain Valley, California, 92708, United States

Location

SC3 Research-Reseda

Pasadena, California, 91105, United States

Location

The Neurology Group

Pomona, California, 91767, United States

Location

SC3 Research-Reseda

Reseda, California, 91335, United States

Location

CNS Network

Torrance, California, 90502, United States

Location

Associated Neurologists, P.C.

Danbury, Connecticut, 06810, United States

Location

Parkinson's Disease and Movement Disorder Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

University of Florida

Gainesville, Florida, 32607, United States

Location

Parkinson's Disease Treatment Center of SW Florida

Port Charlotte, Florida, 33980, United States

Location

Infinity Clinical Research, LLC

Sunrise, Florida, 33351, United States

Location

Tallahassee Neurological Clinic, P.A.

Tallahassee, Florida, 32308, United States

Location

SRI Biosciences, Clinical Trials and Strategic Development Services

Plymouth, Michigan, 48170, United States

Location

Washington University School of medicine

St Louis, Missouri, 63110, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

David L. Kreitzman, MD, PC

Commack, New York, 11725, United States

Location

Asheville Neurology Specialists, PA

Asheville, North Carolina, 28806, United States

Location

Neurology/Neurophysiology

Johnstown, Pennsylvania, 15904, United States

Location

Booth Gardner Parkinson's Care Center

Kirkland, Washington, 98034, United States

Location

Inland Northwest Research

Spokane, Washington, 99202, United States

Location

Related Publications (1)

• DeKarske D, Alva G, Aldred JL, Coate B, Cantillon M, Jacobi L, Nunez R, Norton JC, Abler V. An Open-Label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults with Parkinson's Disease and Depression. J Parkinsons Dis. 2020;10(4):1751-1761. doi: 10.3233/JPD-202058.

  PMID: 32804101 DERIVED

MeSH Terms

Interventions

pimavanserin

Results Point of Contact

• Title: Sr. Dir. Medical Information and Medical Communications
• Organization: ACADIA Pharmaceuticals Inc.

medicalinformation@acadia-pharm.com

858-261-2897

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: March 29, 2018
• Study Start: March 9, 2018
• Primary Completion: July 9, 2019
• Study Completion: July 24, 2019
• Last Updated: August 31, 2020
• Results First Posted: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)