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

A Pilot Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine

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

Study Overview

• Status: Terminated
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Pimavanserin; Other: Placebo; Drug: Quetiapine

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Movement Disorders Center of Arizona
    • Tucson, Arizona, United States, 85710
      • Tucson Neuroscience Research
  • California
    • Sacramento, California, United States, 95816
      • Sutter Institute for Medical Research
  • Florida
    • Hialeah, Florida, United States, 30016
      • Galiz Research
    • Lady Lake, Florida, United States, 32159
      • Charter Research, LLC
    • Miami, Florida, United States, 33122
      • Premier Clinical Research Institute, Inc.
    • Sunrise, Florida, United States, 33351
      • Infinity Clinical Research, LLC
    • Winter Park, Florida, United States, 32792
      • Charter Research, LLC
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Pacific Neuroscience, LLC.
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of lowa Hospital and Clinics
  • Michigan
    • Plymouth, Michigan, United States, 48170
      • SRI International
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc.
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Dayton Center for Neurological Disorders
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Prisma Health-Upstate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subjects 50 to 85 years of age, inclusive
2. Able to understand the protocol requirements and provide written informed consent
3. Able to complete questions on a handheld device / tablet, is willing to wear an actigraph and can be reliably rated on assessment scales
4. 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
5. Is able to swallow the test capsule without difficulty during the Screening visit
6. Has a Mini-Mental State Examination (MMSE) score ≥19
7. 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.
8. Has non-motor neuropsychiatric symptoms severe enough to warrant treatment with an antipsychotic agent based on investigator judgement and CGI-S score
9. 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)
10. 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.

Exclusion Criteria:

1. Has atypical parkinsonism or secondary parkinsonism variants such as tardive or medication induced parkinsonism
2. Is in hospice, is receiving end-of-life palliative care, or is bedridden or confined to a wheelchair
3. Has neuropsychiatric symptoms that are primarily attributable to current delirium or substance abuse
4. 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
5. Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
6. Has orthostatic hypotension as judged by the investigator and medical monitor
7. 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

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all pre-specified entry criteria).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug - pimavanserin; Pimavanserin 34 mg provided as 2 x 17 mg encapsulated tablets	Drug: Pimavanserin; Pimavanserin 34 mg (provided as 2×17 mg encapsulated tablets) administered orally as a single dose once daily
Placebo Comparator: Placebo; Placebo encapsulated tablet	Other: Placebo; Placebo (provided as 2 × placebo encapsulated tablets) administered orally as a single dose once daily
Active Comparator: Quetiapine; Immediate release Quetiapine encapsulated tablets	Drug: Quetiapine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ACADIA Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Actual): September 25, 2020
• Study Completion (Actual): September 25, 2020

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Antiparkinson Agents; Anti-Dyskinesia Agents; Quetiapine Fumarate; Pimavanserin
• Other Study ID Numbers: ACP-103-056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No