Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine
NCT ID: NCT04164758
Last Updated: 2021-10-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
11 participants
INTERVENTIONAL
2019-10-23
2020-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Drug - pimavanserin
Pimavanserin 34 mg provided as 2 x 17 mg encapsulated tablets
Pimavanserin
Pimavanserin 34 mg (provided as 2×17 mg encapsulated tablets) administered orally as a single dose once daily
Placebo
Placebo encapsulated tablet
Placebo
Placebo (provided as 2 × placebo encapsulated tablets) administered orally as a single dose once daily
Quetiapine
Immediate release Quetiapine encapsulated tablets
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
Interventions
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Pimavanserin
Pimavanserin 34 mg (provided as 2×17 mg encapsulated tablets) administered orally as a single dose once daily
Placebo
Placebo (provided as 2 × placebo encapsulated tablets) administered orally as a single dose once daily
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
Eligibility Criteria
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Inclusion Criteria
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
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
50 Years
85 Years
ALL
No
Sponsors
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ACADIA Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Movement Disorders Center of Arizona
Scottsdale, Arizona, United States
Tucson Neuroscience Research
Tucson, Arizona, United States
Sutter Institute for Medical Research
Sacramento, California, United States
Galiz Research
Hialeah, Florida, United States
Charter Research, LLC
Lady Lake, Florida, United States
Premier Clinical Research Institute, Inc.
Miami, Florida, United States
Infinity Clinical Research, LLC
Sunrise, Florida, United States
Charter Research, LLC
Winter Park, Florida, United States
Meridian Clinical Research
Savannah, Georgia, United States
Hawaii Pacific Neuroscience, LLC.
Honolulu, Hawaii, United States
University of lowa Hospital and Clinics
Iowa City, Iowa, United States
SRI International
Plymouth, Michigan, United States
Bio Behavioral Health
Toms River, New Jersey, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, United States
Prisma Health-Upstate
Greenville, South Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ACP-103-056
Identifier Type: -
Identifier Source: org_study_id