Pimavanserin for Sleep in Parkinson Disease | NCT05796167

Studies
Pimavanserin for Sleep in Parkinson Disease

NCT05796167

Sponsor

State University of New York - Downstate Medical Center

Status

Withdrawn

Last Update Posted

Dec 20, 2024Actual

Enrollment

0Actual

Phase

Early Phase 1

Conditions

Parkinson Disease

Interventions

Pimavanserin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1396075255	Other Identifier	Acadia Pharmaceuticals Inc

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Jan 27, 2023Actual

Primary Completion Date

Jun 24, 2024Actual

Completion Date

Jun 24, 2024Actual

First Submitted Date

Jan 31, 2023

First Submission Date that Met QC Criteria

Mar 21, 2023

First Posted Date

Apr 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2024

Last Update Posted Date

Dec 20, 2024Actual

Name	Class
ACADIA Pharmaceuticals Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pimavanserin (Nuplazid)	Experimental	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	Drug: Pimavanserin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pimavanserin	Drug	Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks	Pimavanserin (Nuplazid)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of pimavanserin on sleep fragmentation	Number of arousals and the arousal index (arousals per hour of sleep) measured on polysomnography	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder	Presence fo REM sleep without atonia (RWA) on polysomnograophy	6 weeks
Effect of pimavanserin on sleep latency	Time to first epoch on polysomnography

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian J Amlang, MD	State University of New York - Downstate Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SUNY Downstate Health Sciences University		Brooklyn	New York	11203	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 17, 2023	Apr 3, 2023	Prot_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D006212	Hallucinations
D003702	Delusions

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided