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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04164758
Recruitment Status : Terminated (Study enrollment impacted by COVID-19 pandemic and Sponsor terminated for business reasons)
First Posted : November 15, 2019
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Pimavanserin Other: Placebo Drug: Quetiapine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 23, 2019
Actual Primary Completion Date : September 25, 2020
Actual Study Completion Date : September 25, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Treatment-emergent adverse events (TEAEs) [ Time Frame: 4 Weeks Treatment Duration ]
    Assess the safety and tolerability of pimavanserin and low-dose quetiapine compared to placebo in subjects with Parkinson's disease as measured by treatment-emergent adverse events.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04164758


Locations
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United States, Arizona
Movement Disorders Center of Arizona
Scottsdale, Arizona, United States, 85258
Tucson Neuroscience Research
Tucson, Arizona, United States, 85710
United States, California
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
United States, Florida
Galiz Research
Hialeah, Florida, United States, 30016
Charter Research, LLC
Lady Lake, Florida, United States, 32159
Premier Clinical Research Institute, Inc.
Miami, Florida, United States, 33122
Infinity Clinical Research, LLC
Sunrise, Florida, United States, 33351
Charter Research, LLC
Winter Park, Florida, United States, 32792
United States, Georgia
Meridian Clinical Research
Savannah, Georgia, United States, 31406
United States, Hawaii
Hawaii Pacific Neuroscience, LLC.
Honolulu, Hawaii, United States, 96817
United States, Iowa
University of lowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
United States, Michigan
SRI International
Plymouth, Michigan, United States, 48170
United States, New Jersey
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
United States, North Carolina
M3 Wake Research, Inc.
Raleigh, North Carolina, United States, 27612
United States, Ohio
Dayton Center for Neurological Disorders
Centerville, Ohio, United States, 45459
United States, South Carolina
Prisma Health-Upstate
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
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Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT04164758    
Other Study ID Numbers: ACP-103-056
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pimavanserin
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action