Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression
NCT ID: NCT03482882
Last Updated: 2020-08-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2018-03-09
2019-07-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis
NCT04292223
An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients
NCT01518309
A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis
NCT01174004
A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis
NCT06068465
Randomized Placebo Controlled Trial Evaluating the Efficacy of Pimavanserin, a Selective Serotonin 5-HydroxyTryptamine-2A (5HT2A) Inverse Agonist, to Treat Impulse Control Disorders in Parkinson's Disease.
NCT03947216
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Drug - pimavanserin
Pimavanserin
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pimavanserin
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ACADIA Pharmaceuticals Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACP-103-048
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.