Pimavanserin for Sleep in Parkinson Disease

NCT05796167 | Withdrawn Early Phase 1 FDA Drug

• 2 other identifiers: 22-02-723-2051396075255
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Keywords

sleep; visual hallucinations; delusions

Outcome Measures

Primary Outcomes (1)

• Effect of pimavanserin on sleep fragmentation

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

  6 weeks

Secondary Outcomes (8)

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

  6 weeks

• Effect of pimavanserin on sleep latency

  6 weeks

• Effect of pimavanserin on total sleep time

  6 weeks

• Effect of pimavanserin on sleep efficiency

  6 weeks

• Effect of pimavanserin on time in each sleep stage

  6 weeks

Study Arms (1)

Pimavanserin (Nuplazid)

EXPERIMENTAL

Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks for patients with Parkinson disease psychosis (e.g., visual hallucinations, delusions) and sleep problems

Drug: Pimavanserin

Interventions

Pimavanserin DRUG

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

Also known as: Nuplazid

Pimavanserin (Nuplazid)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Has evidence of an atypical or secondary parkinsonian disorder
• Has a contraindication to taking pimavanserin
• Has contraindication to PSG
• 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
• Has traveled through 3 or more time zones within 60 days prior to study screening
• Patient is a night-shift worker

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead
• ACADIA Pharmaceuticals Inc.: collaborator

Study Sites (1)

SUNY Downstate Health Sciences University

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Hallucinations; Delusions

Interventions

pimavanserin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Christian J Amlang, MD

  State University of New York - Downstate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: self-control, pilot study

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: April 3, 2023
• Study Start: January 27, 2023
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)