Pimavanserin for Sleep in Parkinson Disease
Reason given: The PI did not have eligible candidates. Therefore, Acadia Pharmaceuticals (the sponsor) closed the study.
Key facts
- Where
- Brooklyn, United StatesSee the site
- Phase
- Early phase 1
Where in United States
- SUNY Downstate Health Sciences UniversityBrooklyn, United StatesNo longer taking part
Trial details
- Who runs it
- State University of New York - Downstate Medical Center
- Trial code
- NCT05796167
- Record updated
- 20 December 2024
- Original description
This pilot, self-control study is for patients with Parkinson's Disease (PD) psychosis (e.g., visual hallucinations, delusions) and sleep problems.Read full original descriptionShow less
Does Pimavanserin (Nuplazid) Improve Sleep in Patients With Parkinson Disease Psychosis? A Pilot Study
This pilot, self-control study is for patients with Parkinson's Disease (PD) psychosis (e.g., visual hallucinations, delusions) and sleep problems.
Inclusion: 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.
Exclusion: 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; Has evidence of an atypical or secondary parkinsonian disorder; Has a contraindication to taking pimavanserin; Has contraindication to PSG; Patient is a night-shift worker.