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

A 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease Psychosis
• Intervention / Treatment: Drug: Pimavanserin

Detailed Description

This study will be conducted as a 16-week, multi-center, single-arm, open-label study. Pimavanserin will be administered at a dose of 34 mg to approximately 50 subjects with PDP

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Movement Disorders Center of Arizona
  • California
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
  • Florida
    • Miami, Florida, United States, 33122
      • Premier Clinical Research Institute, Inc.
    • Miami Lakes, Florida, United States, 33016
      • Global Health Research Center, Inc.
    • Pompano Beach, Florida, United States, 33064
      • Quantum Laboratories, Inc.
    • Port Charlotte, Florida, United States, 33980
      • Parkinson's Disease Treatment Center of Southwest Florida
    • Port Orange, Florida, United States, 32127
      • Accel Research Sites - Brain and Spine Institute
    • Sunrise, Florida, United States, 33351
      • Infinity Clinical Research, LLC
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute at Palm Beach Neurology
  • Georgia
    • Augusta, Georgia, United States, 30912
      • AU Movement and Memory Disorders
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Partners Neurology
  • New Hampshire
    • Dover, New Hampshire, United States, 03820
      • Wentworth Health Partners Coastal Neurology Services
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • Ohio
    • Dayton, Ohio, United States, 45459
      • Neurology Diagnostics, Inc.
    • New Albany, Ohio, United States, 43054
      • The Orthopedic Foundation
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Central States Research
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • KCA Neurology
  • Texas
    • Dallas, Texas, United States, 75218
      • Neurological Associates of North Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subjects at least 40 years of age
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:

1. 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
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

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug - Pimavanserin; Pimavanserin 34 mg administered orally	Drug: Pimavanserin; Pimavanserin 34 mg (provided as 1×34 mg capsule), administered orally, once daily for 16 weeks; Other Names: NUPLAZID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline (Week 0) to Week 16 on the modified Functional Status Questionnaire (mFSQ) total score	The mFSQ is a self-administered questionnaire that provides assessment in ambulatory patients of physical, psychological, social, and role function. It comprises 34 core items that produces 6 summary scale scores: Basic activities of daily living; Intermediate activities of daily living; Psychological function and mental health; Social/Role functionWork performanceSocial activityQuality interaction It also includes 6 single-item scores (work situation; days per month in bed due to illness or injury; days per month when illness injury reduced activities normally performed for half a day; satisfaction with sexual relationship; satisfaction with own health; frequency of social interaction)	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to Week 16 on the Schwab and England ADL Scale (Caregiver and Patient Version)	The Schwab & England ADL Scale is widely used in PD. It is rated by physicians, patients, or staff using a 0% to 100% scale with 10% intervals, where 100% is "Completely independent. Unaware of difficulty" and 0% is "Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden"	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 (Caregiver and Patient Version)	The MDS-UPDRS is a comprehensive battery of motor and behavioral indices derived from the Columbia Scale (Fahn et al. 1987). The MDS-UPDRS Parts I and II will be used to assess mentation, behavior and mood (Part 1) and activities of daily living (Part II) and are rater-based examinations consisting of 4 and 13 items, respectively.	16 Weeks
Week 16 Clinical Global Impression - Improvement (CGI-I) score for hallucinations and delusions	The CGI-I is a clinician-rated, 7-point scale that is designed to rate the improvement in the subject's symptoms at the time of assessment, relative to the symptoms at Baseline (Guy 1976). Severity ratings should be based on the behavioral domains of clinical concern, namely 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	The CGI-S scale is a clinician-rated, 7-point scale that is designed to rate the severity of the subject's neuropsychiatric symptoms at the time of assessment using the Investigator's judgment and past experience with subjects who have the same disorder (Guy 1976). Severity ratings should be based on the behavioral domains of clinical concern, namely hallucinations and delusions.	16 Weeks
Week 16 on the Patient Global Impression of Improvement (PGI-I) score for hallucinations and delusions	The PGI-I is a global index used to rate the response of a condition to a therapy. It is a simple, direct, easy to use scale that is intuitively understandable to subjects and clinicians. The PGI-I asks the patient to rate their symptoms now, as compared with how it was at Baseline before beginning treatment, ranging from 1=very much better to 7=very much worse. Severity ratings should be based on the behavioral domains of clinical concern, namely hallucinations and delusions.	16 Weeks

Collaborators and Investigators

• Sponsor: ACADIA Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): April 26, 2022
• Study Completion (Actual): April 26, 2022

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Psychotic Disorders; Parkinson Disease; Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Antiparkinson Agents; Anti-Dyskinesia Agents; Pimavanserin
• Other Study ID Numbers: ACP-103-063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No