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

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ClinicalTrials.gov Identifier: NCT03482882
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Treatment of Depression in Adults With Parkinson's Disease (PD) Drug: Pimavanserin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and Depression
Actual Study Start Date : March 9, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug - pimavanserin Drug: Pimavanserin
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)




Primary Outcome Measures :
  1. Change from Baseline to Week 8 in the Hamilton Depression Scale -17 items (HAMD-17) total score [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 8 weeks ]
  2. Change from Baseline in Clinical Global Impression-Severity (CGI-S) [ Time Frame: 8 weeks ]
  3. Change from Baseline in Scale of Outcomes in PD-Sleep Scale (SCOPA) night time sleep score [ Time Frame: 8 weeks ]
  4. Change from Baseline in SCOPA day time sleepiness score [ Time Frame: 8 weeks ]
  5. Proportion of responders (defined as ≥50% reduction from Baseline in HAMD-17 total score) [ Time Frame: 8 weeks ]
  6. Change from Baseline in EuroQol-5 dimensions-5 levels (EQ-5D-5L) [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Can understand and provide signed informed consent, request for medical records and/or subject privacy form if applicable according to local regulations
  2. 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:

    1. rest tremor
    2. rigidity
    3. bradykinesia and/or akinesia
    4. postural and gait abnormalities
  3. Meets clinical criteria for depression with Parkinson's disease as listed in the NINDS/NIMH Guidelines
  4. 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.
  5. Is on a stable dose of anti-Parkinson's medication for 1 month prior to Screening
  6. If the subject is female, she must be of non-childbearing potential or agree to use two methods of clinically acceptable contraception

Exclusion Criteria:

  1. Use of an antipsychotic within 3 weeks or 5 half-lives of Baseline (whichever is longer)
  2. Had a myocardial infarction within the 6 months prior to Screening
  3. Has a known personal or family history or symptoms of long QT syndrome
  4. Evidence of severe or medically significant hepatic or renal impairment on laboratory tests as assessed by the Investigator or Medical Monitor
  5. Has a history of PD psychosis, schizophrenia, or other psychotic disorder, or bipolar I or II disorder.
  6. Actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
  7. Is pregnant or breastfeeding
  8. Has previously been treated with pimavanserin or is currently taking pimavanserin
  9. Has a sensitivity to pimavanserin or its excipients
  10. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482882


Contacts
Contact: Patrick Kesslak 858-320-8699 pkesslak@acadia-pharm.com
Contact: Lori Jacobi 609-250-6901 ljacobi@acadia-pharm.com

Locations
United States, California
ATP Clinical Research, Inc. Recruiting
Costa Mesa, California, United States, 92626
The Parkinson's and Movement Disorder Institute Recruiting
Fountain Valley, California, United States, 92708
SC3 Research-Reseda Recruiting
Pasadena, California, United States, 91105
The Neurology Group Recruiting
Pomona, California, United States, 91767
SC3 Research-Reseda Recruiting
Reseda, California, United States, 91335
CNS Network Recruiting
Torrance, California, United States, 90502
United States, Connecticut
Associated Neurologists, P.C. Recruiting
Danbury, Connecticut, United States, 06810
United States, Florida
Parkinson's Disease and Movement Disorder Center of Boca Raton Recruiting
Boca Raton, Florida, United States, 33486
University of Florida Recruiting
Gainesville, Florida, United States, 32607
Parkinson's Disease Treatment Center of SW Florida Recruiting
Port Charlotte, Florida, United States, 33980
Infinity Clinical Research, LLC Recruiting
Sunrise, Florida, United States, 33351
Tallahassee Neurological Clinic, P.A. Recruiting
Tallahassee, Florida, United States, 32308
United States, Missouri
Washington University School of medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Bio Behavioral Health Recruiting
Toms River, New Jersey, United States, 08755
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
David L. Kreitzman, MD, PC Recruiting
Commack, New York, United States, 11725
United States, North Carolina
Asheville Neurology Specialists, PA Recruiting
Asheville, North Carolina, United States, 28806
United States, Pennsylvania
Neurology/Neurophysiology Recruiting
Johnstown, Pennsylvania, United States, 15904
United States, Washington
Booth Gardner Parkinson's Care Center Recruiting
Kirkland, Washington, United States, 98034
Inland Northwest Research Recruiting
Spokane, Washington, United States, 99202
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03482882     History of Changes
Other Study ID Numbers: ACP-103-048
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pimavanserin
Depression
Depressive Disorder
Parkinson Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action