WithdrawnEarly Phase 1

Pimavanserin for Sleep in Parkinson Disease

Stopped: The PI did not have eligible candidates. Therefore, Acadia Pharmaceuticals (the sponsor) closed the study.

United States0Started 2023-01-27

Plain-language summary

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

Age range40 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Effect of pimavanserin on sleep fragmentation

Timeframe: 6 weeks

NCT IDNCT05796167

SponsorState University of New York - Downstate Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-24