Clinical trial NCT04292223: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease Psychosis
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-03
Enrollment: 29
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline to Week 16 in Modified Functional Status Questionnaire (mFSQ) Total Score
timeFrame: 16 weeks
Secondary outcomes:
measure: Change From Baseline to Week 16 on the Schwab and England Activity of Daily Living (ADL) Scale, Caregiver and Patient Versions
timeFrame: 16 Weeks
measure: Change From Baseline to Week 16 on the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I and II
timeFrame: 16 Weeks
measure: Week 16 Clinical Global Impression - Improvement (CGI-I) Score for Hallucinations and Delusions
timeFrame: 16 Weeks
measure: Change From Baseline to Week 16 on the Clinical Global Impression - Severity of Illness (CGI-S) Score for Hallucinations and Delusions
timeFrame: 16 Weeks
measure: Patient Global Impression of Improvement (PGI-I) Score for Hallucinations and Delusions at Week 16
timeFrame: 16 Weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Movement Disorders Center of Arizona
state: Arizona
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Miami Lakes
country: United States
facility: Global Health Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute, Inc.
state: Florida
city: Pompano Beach
country: United States
facility: Quantum Laboratories, Inc.
state: Florida
city: Port Charlotte
country: United States
facility: Parkinson's Disease Treatment Center of Southwest Florida
state: Florida
city: Port Orange
country: United States
facility: Accel Research Sites - Brain and Spine Institute
state: Florida
city: Sunrise
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute at Palm Beach Neurology
state: Florida
city: Augusta
country: United States
facility: AU Movement and Memory Disorders
state: Georgia
city: Scarborough
country: United States
facility: Maine Medical Partners Neurology
state: Maine
city: Dover
country: United States
facility: Wentworth Health Partners Coastal Neurology Services
state: New Hampshire
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Dayton
country: United States
facility: Neurology Diagnostics, Inc.
state: Ohio
city: New Albany
country: United States
facility: The Orthopedic Foundation
state: Ohio
city: Tulsa
country: United States
facility: Central States Research
state: Oklahoma
city: Franklin
country: United States
facility: KCA Neurology
state: Tennessee
city: Dallas
country: United States
facility: Neurological Associates of North Texas
state: Texas
Study officials:
References: