Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine

NCT04164758 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: ACP-103-056
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 16

Brief Summary

This is a pilot study to explore the effects of pimavanserin and low-dose quetiapine in subjects with Parkinson's disease with neuropsychiatric symptoms.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent Adverse Events (TEAEs)

  Assess the safety and tolerability of pimavanserin in patients with PD in terms of treatment-emergent adverse events.

  4-week treatment duration, plus 30 days treatment-free safety follow-up

Study Arms (3)

Drug - pimavanserin

EXPERIMENTAL

Pimavanserin 34 mg provided as 2 x 17 mg encapsulated tablets

Drug: Pimavanserin

Placebo

PLACEBO COMPARATOR

Placebo encapsulated tablet

Other: Placebo

Quetiapine

ACTIVE COMPARATOR

Immediate release Quetiapine encapsulated tablets

Drug: Quetiapine

Interventions

Pimavanserin DRUG

Pimavanserin 34 mg (provided as 2×17 mg encapsulated tablets) administered orally as a single dose once daily

Drug - pimavanserin

Placebo OTHER

Placebo (provided as 2 × placebo encapsulated tablets) administered orally as a single dose once daily

Placebo

Quetiapine DRUG

Quetiapine 25 mg (provided as 1×25 mg quetiapine encapsulated tablet and 1 × placebo encapsulated tablet), OR 50 mg (provided as 2×25 mg quetiapine encapsulated tablets), OR 100 mg (provided as 2×50 mg quetiapine encapsulated tablets) administered orally as a single dose once daily

Quetiapine

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects 50 to 85 years of age, inclusive
• Able to understand the protocol requirements and provide written informed consent
• Able to complete questions on a handheld device / tablet, is willing to wear an actigraph and can be reliably rated on assessment scales
• Able to designate an 'informant' (relative, housemate, friend) who can provide information about the subject's well being and attend clinic visits with the subject
• Is able to swallow the test capsule without difficulty during the Screening visit
• Has a Mini-Mental State Examination (MMSE) score ≥19
• Has a diagnosis of idiopathic Parkinson's disease, without any other known or suspected cause of parkinsonism. Initial diagnosis of PD must have been made more than 1 year prior to Screening.
• Has non-motor neuropsychiatric symptoms severe enough to warrant treatment with an antipsychotic agent based on investigator judgement and CGI-S score
• If the subject is on anti-Parkinsonian medication, they must be on a stable regimen for 1 month prior to Baseline and not planning (at the time of the Baseline visit) to make a major change in dose(s)
• If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential or must agree to use a clinically acceptable method of contraception or be abstinent for at least 1 month prior to the Baseline visit, during the study, and 41 days following completion of double-blind treatment.

You may not qualify if:

• Has atypical parkinsonism or secondary parkinsonism variants such as tardive or medication induced parkinsonism
• Is in hospice, is receiving end-of-life palliative care, or is bedridden or confined to a wheelchair
• Has neuropsychiatric symptoms that are primarily attributable to current delirium or substance abuse
• 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 known personal or family history of long QT syndrome or family history of sudden cardiac death
• Has orthostatic hypotension as judged by the investigator and medical monitor
• Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason, including if the subject is judged to be a danger to self or others

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (16)

Movement Disorders Center of Arizona

Scottsdale, Arizona, 85258, United States

Location

Tucson Neuroscience Research

Tucson, Arizona, 85710, United States

Location

Sutter Institute for Medical Research

Sacramento, California, 95816, United States

Location

Galiz Research

Hialeah, Florida, 30016, United States

Location

Charter Research, LLC

Lady Lake, Florida, 32159, United States

Location

Premier Clinical Research Institute, Inc.

Miami, Florida, 33122, United States

Location

Infinity Clinical Research, LLC

Sunrise, Florida, 33351, United States

Location

Charter Research, LLC

Winter Park, Florida, 32792, United States

Location

Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

Hawaii Pacific Neuroscience, LLC.

Honolulu, Hawaii, 96817, United States

Location

University of lowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

SRI International

Plymouth, Michigan, 48170, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

Dayton Center for Neurological Disorders

Centerville, Ohio, 45459, United States

Location

Prisma Health-Upstate

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

pimavanserin; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. It was restarted in Jun 2020 and paused again in Aug 2020. Subsequently, no further patients were enrolled. On 24 Sep 2020, the sponsor decided to permanently stop the study.

Results Point of Contact

• Title: Sr. Dir. Medical Information and Medical Communications
• Organization: Acadia Pharmaceuticals Inc.

medicalinformation@acadia-pharm.com

858-261

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 15, 2019
• Study Start: October 23, 2019
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2020
• Last Updated: October 14, 2021
• Results First Posted: October 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)