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

Primary Purpose

Parkinson Disease Psychosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pimavanserin
Sponsored by
ACADIA Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease Psychosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Movement Disorders Center of Arizona
  • Neurology Center of North Orange County
  • Global Health Research Center, Inc.
  • Premier Clinical Research Institute, Inc.
  • Quantum Laboratories, Inc.
  • Parkinson's Disease Treatment Center of Southwest Florida
  • Accel Research Sites - Brain and Spine Institute
  • Infinity Clinical Research, LLC
  • Premiere Research Institute at Palm Beach Neurology
  • AU Movement and Memory Disorders
  • Maine Medical Partners Neurology
  • Wentworth Health Partners Coastal Neurology Services
  • Bio Behavioral Health
  • Neurology Diagnostics, Inc.
  • The Orthopedic Foundation
  • Central States Research
  • KCA Neurology
  • Neurological Associates of North Texas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug - Pimavanserin

Arm Description

Pimavanserin 34 mg administered orally

Outcomes

Primary Outcome Measures

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 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

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"
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.
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.
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.
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.

Full Information

First Posted
February 28, 2020
Last Updated
August 31, 2022
Sponsor
ACADIA Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04292223
Brief Title
Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
April 26, 2022 (Actual)
Study Completion Date
April 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACADIA Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug - Pimavanserin
Arm Type
Experimental
Arm Description
Pimavanserin 34 mg administered orally
Intervention Type
Drug
Intervention Name(s)
Pimavanserin
Other Intervention Name(s)
NUPLAZID
Intervention Description
Pimavanserin 34 mg (provided as 1×34 mg capsule), administered orally, once daily for 16 weeks
Primary Outcome Measure Information:
Title
Change from baseline (Week 0) to Week 16 on the modified Functional Status Questionnaire (mFSQ) total score
Description
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)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to Week 16 on the Schwab and England ADL Scale (Caregiver and Patient Version)
Description
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"
Time Frame
16 Weeks
Title
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)
Description
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.
Time Frame
16 Weeks
Title
Week 16 Clinical Global Impression - Improvement (CGI-I) score for hallucinations and delusions
Description
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.
Time Frame
16 Weeks
Title
Change from Baseline to Week 16 on the Clinical Global Impression - Severity of Illness (CGI-S) score for hallucinations and delusions
Description
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.
Time Frame
16 Weeks
Title
Week 16 on the Patient Global Impression of Improvement (PGI-I) score for hallucinations and delusions
Description
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.
Time Frame
16 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Movement Disorders Center of Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Global Health Research Center, Inc.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Premier Clinical Research Institute, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Quantum Laboratories, Inc.
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Parkinson's Disease Treatment Center of Southwest Florida
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Accel Research Sites - Brain and Spine Institute
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Infinity Clinical Research, LLC
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Premiere Research Institute at Palm Beach Neurology
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
AU Movement and Memory Disorders
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Maine Medical Partners Neurology
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Wentworth Health Partners Coastal Neurology Services
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Neurology Diagnostics, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
The Orthopedic Foundation
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054
Country
United States
Facility Name
Central States Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
KCA Neurology
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Neurological Associates of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75218
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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