Pimavanserin for Sleep in Parkinson Disease

Last updated: December 17, 2024
Sponsor: State University of New York - Downstate Medical Center
Overall Status: Trial Not Available

Phase

1

Condition

N/A

Treatment

Pimavanserin

Clinical Study ID

NCT05796167
22-02-723-205
1396075255
  • Ages 40-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Study Design

Treatment Group(s): 1
Primary Treatment: Pimavanserin
Phase: 1
Study Start date:
January 27, 2023
Estimated Completion Date:
June 24, 2024

Study 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

Connect with a study center

  • SUNY Downstate Health Sciences University

    Brooklyn, New York 11203
    United States

    Site Not Available

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