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Pimavanserin for Sleep in Parkinson Disease

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Pimavanserin
Sponsored by
State University of New York - Downstate Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring sleep, visual hallucinations, delusions

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: 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 criteria 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Pimavanserin (Nuplazid)

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    Effect of pimavanserin on sleep fragmentation
    Number of arousals and the arousal index (arousals per hour of sleep) measured on polysomnography

    Secondary Outcome Measures

    Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder
    Presence fo REM sleep without atonia (RWA) on polysomnograophy
    Effect of pimavanserin on sleep latency
    Time to first epoch on polysomnography
    Effect of pimavanserin on total sleep time
    Total sleep time measured on polysomnography
    Effect of pimavanserin on sleep efficiency
    Sleep Efficiency Index in percent is the ratio of total sleep time (based on polysomnography recordings) to time in bed
    Effect of pimavanserin on time in each sleep stage
    Time in each sleep stage as measured on polysomnography
    Effect of pimavanserin on subjective measure of REM Sleep behavior disorder
    RBDSQ (REM (Rapid Eye Movements) Sleep Behavior Disorder Screening Questionnaire to assess the most prominent clinical features of RBD. It is a 10-item, patient self-rating instrument with short questions to be answered by either 'yes' or 'no'.
    Effect of pimavanserin on subjective measures of sleep
    PDSS-2 (Parkinson's Disease Sleep Scale Version 2) total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). Scores > 18 are considered as relevant sleep disturbances
    Effect of pimavanserin on subjective measures of fatigue
    PFS-16 (Parkinson's disease Fatigue Scale): 16-item scale with the following scoring for each item: strong disagree -1, disagree - 2, neither agree or disagree - 3, agree - 4, strongly agree - 5; with overall score of ≥8 indicates the presence of significant fatigue.

    Full Information

    First Posted
    January 31, 2023
    Last Updated
    April 3, 2023
    Sponsor
    State University of New York - Downstate Medical Center
    Collaborators
    ACADIA Pharmaceuticals Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05796167
    Brief Title
    Pimavanserin for Sleep in Parkinson Disease
    Official Title
    Does Pimavanserin (Nuplazid) Improve Sleep in Patients With Parkinson Disease Psychosis? A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 31, 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    State University of New York - Downstate Medical Center
    Collaborators
    ACADIA Pharmaceuticals Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    sleep, visual hallucinations, delusions

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Model Description
    self-control, pilot study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pimavanserin (Nuplazid)
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Pimavanserin
    Other Intervention Name(s)
    Nuplazid
    Intervention Description
    Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks
    Primary Outcome Measure Information:
    Title
    Effect of pimavanserin on sleep fragmentation
    Description
    Number of arousals and the arousal index (arousals per hour of sleep) measured on polysomnography
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder
    Description
    Presence fo REM sleep without atonia (RWA) on polysomnograophy
    Time Frame
    6 weeks
    Title
    Effect of pimavanserin on sleep latency
    Description
    Time to first epoch on polysomnography
    Time Frame
    6 weeks
    Title
    Effect of pimavanserin on total sleep time
    Description
    Total sleep time measured on polysomnography
    Time Frame
    6 weeks
    Title
    Effect of pimavanserin on sleep efficiency
    Description
    Sleep Efficiency Index in percent is the ratio of total sleep time (based on polysomnography recordings) to time in bed
    Time Frame
    6 weeks
    Title
    Effect of pimavanserin on time in each sleep stage
    Description
    Time in each sleep stage as measured on polysomnography
    Time Frame
    6 weeks
    Title
    Effect of pimavanserin on subjective measure of REM Sleep behavior disorder
    Description
    RBDSQ (REM (Rapid Eye Movements) Sleep Behavior Disorder Screening Questionnaire to assess the most prominent clinical features of RBD. It is a 10-item, patient self-rating instrument with short questions to be answered by either 'yes' or 'no'.
    Time Frame
    6 weeks
    Title
    Effect of pimavanserin on subjective measures of sleep
    Description
    PDSS-2 (Parkinson's Disease Sleep Scale Version 2) total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). Scores > 18 are considered as relevant sleep disturbances
    Time Frame
    6 weeks
    Title
    Effect of pimavanserin on subjective measures of fatigue
    Description
    PFS-16 (Parkinson's disease Fatigue Scale): 16-item scale with the following scoring for each item: strong disagree -1, disagree - 2, neither agree or disagree - 3, agree - 4, strongly agree - 5; with overall score of ≥8 indicates the presence of significant fatigue.
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: 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 criteria 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sofya Glazman
    Phone
    7182707371
    Email
    sofya.glazman@downstate.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Daphne Robakis, MD
    Email
    daphne.robakis@downstate.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daphne Robakis, MD
    Organizational Affiliation
    State University of New York - Downstate Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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