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

NCT04292223 | Completed Phase 4 Results FDA Drug

• 1 other identifier: ACP-103-063
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 18

Brief Summary

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

Conditions

Parkinson Disease Psychosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 16 in Modified Functional Status Questionnaire (mFSQ) Total Score

  The mFSQ is a self-administered questionnaire. It comprises 34 core items that produce 6 summary scale scores (i.e. basic activities of daily living (ADL); intermediate ADL; psychological function and mental health; work performance, social activity, and quality of interaction) and 6 single-item scores (work situation; days/month in bed due to illness/injury; days/month when illness/injury reduced activities normally performed for half a day; satisfaction with sexual relationship; satisfaction with health; frequency of social interaction). The mFSQ is calculated as the unweighted mean of predefined subscale scores. The maximum mFSQ total score is 100, with higher scores indicating better functional status. The minimum score is 0 and the maximum score is 100.

  16 weeks

Secondary Outcomes (5)

• Change From Baseline to Week 16 on the Schwab and England Activity of Daily Living (ADL) Scale, Caregiver and Patient Versions

  16 Weeks

• Change From Baseline to Week 16 on the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I and II

  16 Weeks

• Week 16 Clinical Global Impression - Improvement (CGI-I) Score for Hallucinations and Delusions

  16 Weeks

• Change From Baseline to Week 16 on the Clinical Global Impression - Severity of Illness (CGI-S) Score for Hallucinations and Delusions

  16 Weeks

• Patient Global Impression of Improvement (PGI-I) Score for Hallucinations and Delusions at Week 16

  16 Weeks

Study Arms (1)

Drug - Pimavanserin

EXPERIMENTAL

Pimavanserin 34 mg administered orally

Drug: Pimavanserin

Interventions

Pimavanserin DRUG

Pimavanserin 34 mg (provided as 1×34 mg capsule), administered orally, once daily for 16 weeks

Also known as: NUPLAZID

Drug - Pimavanserin

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (18)

Movement Disorders Center of Arizona

Scottsdale, Arizona, 85258, United States

Location

Neurology Center of North Orange County

Fullerton, California, 92835, United States

Location

Premier Clinical Research Institute, Inc.

Miami, Florida, 33122, United States

Location

Global Health Research Center, Inc.

Miami Lakes, Florida, 33016, United States

Location

Quantum Laboratories, Inc.

Pompano Beach, Florida, 33064, United States

Location

Parkinson's Disease Treatment Center of Southwest Florida

Port Charlotte, Florida, 33980, United States

Location

Accel Research Sites - Brain and Spine Institute

Port Orange, Florida, 32127, United States

Location

Infinity Clinical Research, LLC

Sunrise, Florida, 33351, United States

Location

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, 33407, United States

Location

AU Movement and Memory Disorders

Augusta, Georgia, 30912, United States

Location

Maine Medical Partners Neurology

Scarborough, Maine, 04074, United States

Location

Wentworth Health Partners Coastal Neurology Services

Dover, New Hampshire, 03820, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

Neurology Diagnostics, Inc.

Dayton, Ohio, 45459, United States

Location

The Orthopedic Foundation

New Albany, Ohio, 43054, United States

Location

Central States Research

Tulsa, Oklahoma, 74136, United States

Location

KCA Neurology

Franklin, Tennessee, 37067, United States

Location

Neurological Associates of North Texas

Dallas, Texas, 75218, United States

Location

Related Publications (1)

• 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.

  PMID: 38476466 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

+1-858-261

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 3, 2020
• Study Start: February 10, 2020
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)