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

Parkinson Disease Psychosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292223
• Other study ID #: ACP-103-063
• Status: Completed
• Phase: Phase 4
• Start date: February 10, 2020
• Est. completion date: April 26, 2022

Study information

• Verified date: August 2022
• Source: ACADIA Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 26, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Parkinson Disease
• Parkinson Disease Psychosis
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
United States	AU Movement and Memory Disorders	Augusta	Georgia
United States	Neurological Associates of North Texas	Dallas	Texas
United States	Neurology Diagnostics, Inc.	Dayton	Ohio
United States	Wentworth Health Partners Coastal Neurology Services	Dover	New Hampshire
United States	KCA Neurology	Franklin	Tennessee
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	The Orthopedic Foundation	New Albany	Ohio
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	Maine Medical Partners Neurology	Scarborough	Maine
United States	Movement Disorders Center of Arizona	Scottsdale	Arizona
United States	Infinity Clinical Research, LLC	Sunrise	Florida
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Central States Research	Tulsa	Oklahoma
United States	Premiere Research Institute at Palm Beach Neurology	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ACADIA Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	16 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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