Clinical trial NCT05796167: Pimavanserin for Sleep in Parkinson Disease
Official title: Does Pimavanserin (Nuplazid) Improve Sleep in Patients With Parkinson Disease Psychosis? A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Parkinson Disease
Keywords: sleep
visual hallucinations
delusions
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
Collaborators: name: ACADIA Pharmaceuticals Inc.
First posted: 2023-04-03
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: self-control, pilot study
Primary purpose: OTHER

Brief summary: This pilot, self-control study is for patients with Parkinson's Disease (PD) psychosis (e.g., visual hallucinations, delusions) and sleep problems.

Detailed description: This is a feasibility study to determine whether pimavanserin improves sleep quality in patients with PD and visual hallucinations/delusions.

Patients will complete a Screening Visit to assess eligibility to participate in the study.

For more information, please contact Sofya Glazman, a study coordinator, at sofya.glazman@downstate.edu

Eligibility criteria: Inclusion criteria:

1. Has a diagnosis of idiopathic PD according to UK (United Kingdom) PD Society Brain Bank diagnostic criteria
2. Has a history of hallucinations or delusions associated with PD
3. Has a history of sleep disturbance
4. Is between the ages of 40 and 85
5. Has been on a stable dose of all PD medications for at least 30 days prior to enrolment

Exclusion criteria

1. Has evidence of an atypical or secondary parkinsonian disorder
2. Has a contraindication to taking pimavanserin
3. Has contraindication to PSG
4. There has been a change to patient's neuropsychiatric medications including dopaminergic medications (Sinemet, dopamine agonists, MAO(monoamine oxidaze)-B inhibitors), SSRIs (Selective Serotonin Reuptake Inhibitors), SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), dopamine-blocking agents, anti-epileptics, anticholinergics, or benzodiazepines for at least 30 days prior to enrollment
5. Has traveled through 3 or more time zones within 60 days prior to study screening
6. Patient is a night-shift worker

Primary outcomes:
measure: Effect of pimavanserin on sleep fragmentation
timeFrame: 6 weeks
Secondary outcomes:
measure: Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder
timeFrame: 6 weeks
measure: Effect of pimavanserin on sleep latency
timeFrame: 6 weeks
measure: Effect of pimavanserin on total sleep time
timeFrame: 6 weeks
measure: Effect of pimavanserin on sleep efficiency
timeFrame: 6 weeks
measure: Effect of pimavanserin on time in each sleep stage
timeFrame: 6 weeks
measure: Effect of pimavanserin on subjective measure of REM Sleep behavior disorder
timeFrame: 6 weeks
measure: Effect of pimavanserin on subjective measures of sleep
timeFrame: 6 weeks
measure: Effect of pimavanserin on subjective measures of fatigue
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: SUNY Downstate Health Sciences University
state: New York
Study officials:
affiliation: State University of New York - Downstate Medical Center
name: Christian J Amlang, MD
role: PRINCIPAL_INVESTIGATOR
References: