Pimavanserin for Sleep in Parkinson Disease

Withdrawn before enrolling · Early Phase 1

Conditions studied: Parkinson Disease

In brief

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

Key facts

Study ID

NCT05796167

Run by

State University of New York - Downstate Medical Center

People needed

0

Starts

2023-01-27

Expected to finish

2024-06-24

Last updated by the study team

2024-12-20

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• SUNY Downstate Health Sciences University — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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