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

Sponsor
ACADIA Pharmaceuticals Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04292223
Collaborator
(none)
53
Enrollment
18
Locations
1
Arm
26.6
Anticipated Duration (Months)
2.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
53 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 10, 2020
Anticipated Primary Completion Date :
Apr 26, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline (Week 0) to Week 16 on the modified Functional Status Questionnaire (mFSQ) total score [16 weeks]

      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 function Work performance Social activity Quality 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)

    Secondary Outcome Measures

    1. Change from baseline to Week 16 on the Schwab and England ADL Scale (Caregiver and Patient Version) [16 Weeks]

      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"

    2. 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) [16 Weeks]

      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.

    3. Week 16 Clinical Global Impression - Improvement (CGI-I) score for hallucinations and delusions [16 Weeks]

      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.

    4. Change from Baseline to Week 16 on the Clinical Global Impression - Severity of Illness (CGI-S) score for hallucinations and delusions [16 Weeks]

      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.

    5. Week 16 on the Patient Global Impression of Improvement (PGI-I) score for hallucinations and delusions [16 Weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    6. greater than New York Heart Association (NYHA) Class 2 congestive heart failure

    7. Grade 2 or greater angina pectoris (by Canadian Cardiovascular Society Angina Grading Scale)

    8. sustained ventricular tachycardia

    9. ventricular fibrillation

    10. torsades de pointes

    11. syncope due to an arrhythmia

    12. an implantable cardiac defibrillator

    13. Has a known personal or family history of long QT syndrome or family history of sudden cardiac death

    14. Requires treatment with a medication or other substance that is prohibited by the protocol

    15. 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

    16. Is suicidal at Screening or Baseline

    17. 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

    18. Had dementia prior to or concomitantly with the onset of motor symptoms of PD

    19. Positive COVID-19 polymerase chain reaction (PCR) or antigen result in the last 2 weeks prior to screening

    20. 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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • ACADIA Pharmaceuticals Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ACADIA Pharmaceuticals Inc.
    ClinicalTrials.gov Identifier:
    NCT04292223
    Other Study ID Numbers:
    • ACP-103-063
    First Posted:
    Mar 3, 2020
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease
    Psychotic Disorders
    Mental Disorders
    Pimavanserin

    Study Results

    No Results Posted as of Apr 25, 2022