Pimavanserin for Sleep in Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

Does Pimavanserin (Nuplazid) Improve Sleep in Patients With Parkinson Disease Psychosis? A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796167
• Other study ID #: 22-02-723-205
• Secondary ID: 1396075255
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 4, 2024
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: State University of New York - Downstate Medical Center
• Contact: Sofya Glazman
• Phone: 7182702841
• Email: sofya.glazman[@]downstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion criteria:

1. Has a diagnosis of idiopathic PD according to UK (United Kingdom) PD Society Brain Bank diagnostic 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

1. Has evidence of an atypical or secondary parkinsonian disorder

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Pimavanserin
Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks

Locations

Country	Name	City	State
United States	SUNY Downstate Health Sciences University	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Downstate Medical Center	ACADIA Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of pimavanserin on sleep fragmentation	Number of arousals and the arousal index (arousals per hour of sleep) measured on polysomnography	6 weeks
Secondary	Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder	Presence fo REM sleep without atonia (RWA) on polysomnograophy	6 weeks
Secondary	Effect of pimavanserin on sleep latency	Time to first epoch on polysomnography	6 weeks
Secondary	Effect of pimavanserin on total sleep time	Total sleep time measured on polysomnography	6 weeks
Secondary	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	6 weeks
Secondary	Effect of pimavanserin on time in each sleep stage	Time in each sleep stage as measured on polysomnography	6 weeks
Secondary	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'.	6 weeks
Secondary	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	6 weeks
Secondary	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.	6 weeks