Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2023-01-27
2024-06-24
Brief Summary
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Detailed Description
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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 [email protected]
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Pimavanserin (Nuplazid)
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
Pimavanserin
Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks
Interventions
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Pimavanserin
Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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
40 Years
85 Years
ALL
No
Sponsors
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ACADIA Pharmaceuticals Inc.
INDUSTRY
State University of New York - Downstate Medical Center
OTHER
Responsible Party
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Principal Investigators
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Christian J Amlang, MD
Role: PRINCIPAL_INVESTIGATOR
State University of New York - Downstate Medical Center
Locations
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SUNY Downstate Health Sciences University
Brooklyn, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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1396075255
Identifier Type: OTHER
Identifier Source: secondary_id
22-02-723-205
Identifier Type: -
Identifier Source: org_study_id