Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis

Completed · Phase 4

Conditions studied: Parkinson Disease Psychosis

In brief

To assess the effect of pimavanserin on the activities of daily living in subjects with Parkinson's Disease Psychosis

Key facts

Study ID

NCT04292223

Run by

ACADIA Pharmaceuticals Inc.

People needed

29

Starts

2020-02-10

Expected to finish

2022-04-26

Last updated by the study team

2025-01-14

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects at least 40 years of age
• Has a Mini-Mental State Examination (MMSE) score ≥19 at Screening
• Has a diagnosis of idiopathic Parkinson's disease (PD)
• Has psychotic symptoms that may impair function and are severe enough to warrant treatment with an antipsychotic agent
• Psychotic symptoms developed after the onset of symptoms of PD
• 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.

You may not qualify if…

• Has atypical parkinsonism (Parkinson's plus, multiple system atrophy [MSA], progressive supranuclear palsy [PSP]), or secondary parkinsonism variants such as tardive or medication induced parkinsonism
• Has undergone ablative procedures such as a pallidotomy, thalamotomy, or treatment with focused ultrasound, or has an implanted deep brain stimulator
• 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
• Has a history of myocardial infarction, unstable angina, acute coronary syndrome, or cerebrovascular accident within the last 6 months prior to Screening
• Has any of the following:
• greater than New York Heart Association (NYHA) Class 2 congestive heart failure
• Grade 2 or greater angina pectoris (by Canadian Cardiovascular Society Angina Grading Scale)
• sustained ventricular tachycardia
• ventricular fibrillation
• torsades de pointes
• syncope due to an arrhythmia
• an implantable cardiac defibrillator
• Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
• Requires treatment with a medication or other substance that is prohibited by the protocol
• 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
• Is suicidal at Screening or Baseline
• 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
• Had dementia prior to or concomitantly with the onset of motor symptoms of PD
• Positive COVID-19 polymerase chain reaction (PCR) or antigen result in the last 2 weeks prior to screening
• Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
• 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

• 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

Full record on ClinicalTrials.gov

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