Pimavanserin for Sleep in Parkinson Disease

Early Phase 1WithdrawnNCT05796167

State University of New York - Downstate Medical Center

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Conditions

Parkinson Disease

Interventions

PimavanserinDRUG

Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

SUNY Downstate Health Sciences University

Brooklyn, New York, United States

Outcomes

Primary Outcomes

Effect of pimavanserin on sleep fragmentation

Number of arousals and the arousal index (arousals per hour of sleep) measured on polysomnography

Time frame: 6 weeks

Secondary Outcomes

Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder

Presence fo REM sleep without atonia (RWA) on polysomnograophy

Time frame: 6 weeks

Effect of pimavanserin on sleep latency

Time to first epoch on polysomnography

Time frame: 6 weeks

Effect of pimavanserin on total sleep time

Total sleep time measured on polysomnography

Time frame: 6 weeks

Effect of pimavanserin on sleep efficiency

Sleep Efficiency Index in percent is the ratio of total sleep time (based on polysomnography recordings) to time in bed

Time frame: 6 weeks

Effect of pimavanserin on time in each sleep stage

Time in each sleep stage as measured on polysomnography

Time frame: 6 weeks

Effect of pimavanserin on subjective measure of REM Sleep behavior disorder

RBDSQ (REM (Rapid Eye Movements) Sleep Behavior Disorder Screening Questionnaire to assess the most prominent clinical features of RBD. It is a 10-item, patient self-rating instrument with short questions to be answered by either 'yes' or 'no'.

Time frame: 6 weeks

Effect of pimavanserin on subjective measures of sleep

Data from ClinicalTrials.gov

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