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NCT04373317 · ClinicalTrials.gov registry record · Phase 4
Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
A Phase 4 study of Parkinson's Disease Psychosis, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 358
- Enrollment target
- 20
- Study locations
NCT04373317 is a Phase 4 study of Parkinson's Disease Psychosis that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 358 participants, above the 197-participant average among 3 other Parkinson's Disease Psychosis trials with a reported enrollment target (82% higher). The trial reports 20 study locations across 16 states.
The verdict
NCT04373317, a Phase 4 study of Parkinson's Disease Psychosis, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 358 participants
- Enrollment target
- 20
- Study locations
Study Summary
Patients with Parkinson's disease (PD) sometimes experience symptoms affecting their movement, such as slowness, tremor, stiffness, and balance or walking problems. Many patients also have other symptoms not related to movement, called non-motor symptoms, which may affect one's mood or emotions, memory or thinking, or cause one to see or hear things that aren't real (hallucinations) or believe things that aren't true (delusions). Hallucinations or delusions, together called psychosis, occur in up to 60% of PD patients at some point in time. Parkinson's disease psychosis can sometimes be associated with decreased quality of life, increased nursing home placement, increased rate of death, and greater caregiver burden. There are approximately 50,000 Veterans with Parkinson's disease receiving care in the VA, and up to 30,000 (60%) of them will experience psychosis at some point in time. Quetiapine is an antipsychotic drug approved by the Food and Drug Administration (FDA) that is the most commonly used medication to treat PD psychosis, but more studies are needed to determine if it works for this condition and is also well tolerated and safe. Pimavanserin is a newer antipsychotic drug approved by the Food and Drug Administration (FDA) specifically to treat PD psychosis, but more studies are needed to determine if it works and its safety. The purpose of this research is to gather additional information on the safety and effectiveness of both Quetiapine and Pimavanserin. By doing this study, the investigators hope to learn which of these medications is the most effective course of treatment for people with PD psychosis. Enrollment is open to Veterans nationwide, see your VA provider about the possibility of being referred to one of the study's Hub sites. This can be done through contact from your provider to the study's NSC (Tamara Boney at 267-303-9829).
Conditions Studied
Interventions
- DRUG Quetiapine
- DRUG Pimavanserin
Study Locations (20)
California
- VA Loma Linda Healthcare System, Loma Linda, CA - Loma Linda
- VA Palo Alto Health Care System, Palo Alto, CA - Palo Alto
- San Francisco VA Medical Center, San Francisco, CA - San Francisco
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA - West Los Angeles
Pennsylvania
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA - Philadelphia
- Philadelphia MultiService Center, Philadelphia, PA - Philadelphia
Arizona
- Southern Arizona VA Health Care System, Tucson, AZ - Tucson
Colorado
- Rocky Mountain Regional VA Medical Center, Aurora, CO - Aurora
Florida
- North Florida/South Georgia Veterans Health System, Gainesville, FL - Gainesville
Illinois
- Edward Hines Jr. VA Hospital, Hines, IL - Hines
Kentucky
- Lexington VA Medical Center, Lexington, KY - Lexington
Michigan
- VA Ann Arbor Healthcare System, Ann Arbor, MI - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 358 participants |
| Start Date | 2022-10-24 |
| Est. Completion | 2027-08-24 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04373317
The ClinicalTrials.gov registry entry for NCT04373317 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 358 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 197-participant average among 3 other Parkinson's Disease Psychosis trials with a reported enrollment target (82% higher). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Parkinson's Disease Psychosis appearing as the primary indexed condition, and to 2 interventions - of which Quetiapine is the first listed.
NCT04373317 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Pennsylvania, Arizona.
Frequently Asked Questions
What is clinical trial NCT04373317 about?
NCT04373317 is a clinical study titled "Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis". Patients with Parkinson's disease (PD) sometimes experience symptoms affecting their movement, such as slowness, tremor, stiffness, and balance or walking problems. Many patients also have other symptoms not related to movement, called non-motor symptoms, which may affect one's mood or emotions, mem...
What is the current status of trial NCT04373317?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 358 participants. The study started on 2022-10-24. Estimated completion is 2027-08-24.
What conditions does trial NCT04373317 study?
This clinical trial studies the following conditions: Parkinson's Disease Psychosis.
What interventions are being tested in trial NCT04373317?
The interventions under investigation include: Quetiapine (DRUG), Pimavanserin (DRUG).
Who is sponsoring clinical trial NCT04373317?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04373317 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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