Pimavanserin for Sleep in Parkinson Disease

• Sponsor: State University of New York - Downstate Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05796167
• Collaborator: ACADIA Pharmaceuticals Inc. (Industry)
• Enrollment: 10
• Arm: 1
• Anticipated Duration (Months): 17.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: Pimavanserin	Early Phase 1

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 [e-mail]

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: self-control, pilot studyself-control, pilot study
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Does Pimavanserin (Nuplazid) Improve Sleep in Patients With Parkinson Disease Psychosis? A Pilot Study
• Anticipated Study Start Date: Mar 31, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Pimavanserin; Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks; Other Names: Nuplazid

Outcome Measures

Primary Outcome Measures

1. Effect of pimavanserin on sleep fragmentation [6 weeks]

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

Secondary Outcome Measures

1. Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder [6 weeks]

   Presence fo REM sleep without atonia (RWA) on polysomnograophy

2. Effect of pimavanserin on sleep latency [6 weeks]

   Time to first epoch on polysomnography

3. Effect of pimavanserin on total sleep time [6 weeks]

   Total sleep time measured on polysomnography

4. Effect of pimavanserin on sleep efficiency [6 weeks]

   Sleep Efficiency Index in percent is the ratio of total sleep time (based on polysomnography recordings) to time in bed

5. Effect of pimavanserin on time in each sleep stage [6 weeks]

   Time in each sleep stage as measured on polysomnography

6. Effect of pimavanserin on subjective measure of REM Sleep behavior disorder [6 weeks]

   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'.

7. Effect of pimavanserin on subjective measures of sleep [6 weeks]

   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

8. Effect of pimavanserin on subjective measures of fatigue [6 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• State University of New York - Downstate Medical Center
• ACADIA Pharmaceuticals Inc.

Investigators

• Principal Investigator: Daphne Robakis, MD, State University of New York - Downstate Medical Center

Study Documents (Full-Text)

• Study Protocol - Jan 17, 2023

More Information

Publications

None provided.

• Responsible Party: State University of New York - Downstate Medical Center
• ClinicalTrials.gov Identifier: NCT05796167
• Other Study ID Numbers: 22-02-723-205; 1396075255
• First Posted: Apr 3, 2023
• Last Update Posted: Apr 5, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by State University of New York - Downstate Medical Center: sleep; visual hallucinations; delusions
• Additional relevant MeSH terms: Parkinson Disease; Pimavanserin

Study Results

No Results Posted as of Apr 5, 2023