Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis
NCT ID: NCT04292223
Last Updated: 2025-01-14
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
PHASE4
29 participants
INTERVENTIONAL
2020-02-10
2022-04-26
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.
Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression
NCT03482882
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 34 mg administered orally
Pimavanserin
Pimavanserin 34 mg (provided as 1×34 mg capsule), administered orally, once daily for 16 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pimavanserin
Pimavanserin 34 mg (provided as 1×34 mg capsule), administered orally, once daily for 16 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Has a Mini-Mental State Examination (MMSE) score ≥19 at Screening
3. Has a diagnosis of idiopathic Parkinson's disease (PD)
4. Has psychotic symptoms that may impair function and are severe enough to warrant treatment with an antipsychotic agent
5. Psychotic symptoms developed after the onset of symptoms of PD
6. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) OR must agree to use TWO clinically acceptable methods of contraception.
Exclusion Criteria
2. Has undergone ablative procedures such as a pallidotomy, thalamotomy, or treatment with focused ultrasound, or has an implanted deep brain stimulator
3. Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or psychiatric disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study
4. Has a history of myocardial infarction, unstable angina, acute coronary syndrome, or cerebrovascular accident within the last 6 months prior to Screening
5. Has any of the following:
1. greater than New York Heart Association (NYHA) Class 2 congestive heart failure
2. Grade 2 or greater angina pectoris (by Canadian Cardiovascular Society Angina Grading Scale)
3. sustained ventricular tachycardia
4. ventricular fibrillation
5. torsades de pointes
6. syncope due to an arrhythmia
7. an implantable cardiac defibrillator
6. Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
7. Requires treatment with a medication or other substance that is prohibited by the protocol
8. Has a body mass index (BMI) \<18.5 kg/m2 or \>35 kg/m2 at Screening or Baseline or known unintentional clinically significant weight loss (i.e., ≥7%) over past 6 months
9. Is suicidal at Screening or Baseline
10. Has a history of a significant psychotic disorder prior to or concomitantly with the onset of PD including, but not limited to, schizophrenia or bipolar disorder
11. Had dementia prior to or concomitantly with the onset of motor symptoms of PD
12. Positive COVID-19 polymerase chain reaction (PCR) or antigen result in the last 2 weeks prior to screening
13. Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
40 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.
Movement Disorders Center of Arizona
Scottsdale, Arizona, United States
Neurology Center of North Orange County
Fullerton, California, United States
Premier Clinical Research Institute, Inc.
Miami, Florida, United States
Global Health Research Center, Inc.
Miami Lakes, Florida, United States
Quantum Laboratories, Inc.
Pompano Beach, Florida, United States
Parkinson's Disease Treatment Center of Southwest Florida
Port Charlotte, Florida, United States
Accel Research Sites - Brain and Spine Institute
Port Orange, Florida, United States
Infinity Clinical Research, LLC
Sunrise, Florida, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
AU Movement and Memory Disorders
Augusta, Georgia, United States
Maine Medical Partners Neurology
Scarborough, Maine, United States
Wentworth Health Partners Coastal Neurology Services
Dover, New Hampshire, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, United States
The Orthopedic Foundation
New Albany, Ohio, United States
Central States Research
Tulsa, Oklahoma, United States
KCA Neurology
Franklin, Tennessee, United States
Neurological Associates of North Texas
Dallas, Texas, 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.
Evidente VGH, DeKarske D, Coate B, Abler V. The effects of treatment with pimavanserin on activities of daily living in patients with Parkinson's disease psychosis: a 16-week, single-arm, open-label study. Ther Adv Neurol Disord. 2024 Mar 11;17:17562864241228350. doi: 10.1177/17562864241228350. eCollection 2024.
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-103-063
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.