NCT04164758TerminatedPhase 2
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
ACADIA Pharmaceuticals Inc.15 sites in 1 country11 target enrollmentStarted: October 23, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- ACADIA Pharmaceuticals Inc.
- Enrollment
- 11
- Locations
- 15
- Primary Endpoint
- Treatment-emergent Adverse Events (TEAEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •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).
Arms & Interventions
Drug - pimavanserin
Experimental
Pimavanserin 34 mg provided as 2 x 17 mg encapsulated tablets
Intervention: Pimavanserin (Drug)
Placebo
Placebo Comparator
Placebo encapsulated tablet
Intervention: Placebo (Other)
Quetiapine
Active Comparator
Immediate release Quetiapine encapsulated tablets
Intervention: Quetiapine (Drug)
Outcomes
Primary Outcomes
Treatment-emergent Adverse Events (TEAEs)
Time Frame: 4-week treatment duration, plus 30 days treatment-free safety follow-up
Assess the safety and tolerability of pimavanserin in patients with PD in terms of treatment-emergent adverse events.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (15)
Loading locations...
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