Clinical trial NCT04164758: Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-15
Enrollment: 11
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Treatment-emergent Adverse Events (TEAEs)
timeFrame: 4-week treatment duration, plus 30 days treatment-free safety follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Movement Disorders Center of Arizona
state: Arizona
city: Tucson
country: United States
facility: Tucson Neuroscience Research
state: Arizona
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Lady Lake
country: United States
facility: Charter Research, LLC
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute, Inc.
state: Florida
city: Sunrise
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Winter Park
country: United States
facility: Charter Research, LLC
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience, LLC.
state: Hawaii
city: Iowa City
country: United States
facility: University of lowa Hospital and Clinics
state: Iowa
city: Plymouth
country: United States
facility: SRI International
state: Michigan
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Centerville
country: United States
facility: Dayton Center for Neurological Disorders
state: Ohio
city: Greenville
country: United States
facility: Prisma Health-Upstate
state: South Carolina
Study officials:
References: