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New treatment option for Parkinson's Disease Psychosis
Official title Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
ClinicalTrials.gov ID: NCT04373317
What this study is testing
What is Pimavanserin?
Pimavanserin is an investigational medicine, given as an once-daily, being studied as a potential treatment for parkinson's disease psychosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older. Healthy volunteers may be eligible.
You may be able to join if
- Veteran
- Age 40 years or older
- Diagnosis of Parkinson's Disease consistent with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
- Psychosis [with Neuropsychiatric Inventory (NPI) hallucinations (B) or delusions (A) score 4 or greater]
- Stable dose of PD medications for at least 2 weeks
You likely can't join if
- Psychosis symptoms severe enough to preclude enrollment in a clinical trial and require prompt clinical care instead
- Treatment with quetiapine \>50 mg/day or pimavanserin in the past 3 months, or quetiapine 50 mg/day or another antipsychotic in the past week prior...
- Deep brain stimulation (DBS) surgery within 3 months or has had stimulator adjustments in the previous 2 weeks
- History of a psychotic disorder prior to PD, including bipolar disorder, schizophrenia, schizoaffective disorder, and major depressive disorder with...
- Suspected atypical parkinsonian disorder or dementia with Lewy bodies (DLB)
- Psychosis secondary to other toxic or metabolic disorder
See the full eligibility criteria
- Veteran
- Age 40 years or older
- Diagnosis of Parkinson's Disease consistent with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
- Psychosis [with Neuropsychiatric Inventory (NPI) hallucinations (B) or delusions (A) score 4 or greater]
- Stable dose of PD medications for at least 2 weeks
- If on an acetylcholinesterase inhibitor (AChEI) initially prescribed at least 3 months prior and stable dose (no dose or medication change) for past month
- Informed other must provide informed consent and agree to attend all study visits. The informed other must be at least 18 years of age and have regular contact with the patient (on average at least 4 days per week and...
- English-speaking INFORMED OTHER
- Age 18 years or older
- Must have regular contact with the patient (on average at least 4 days per week, and at least 2 hours per day, or at least 3 days per week and at least 4 hours pr day, that is with patient) via in-person, video, or...
- Agree to attend all study visits
- Be able to provide informed consent
- English-speaking
- Psychosis symptoms severe enough to preclude enrollment in a clinical trial and require prompt clinical care instead
- Treatment with quetiapine \>50 mg/day or pimavanserin in the past 3 months, or quetiapine 50 mg/day or another antipsychotic in the past week prior to study randomization
- Deep brain stimulation (DBS) surgery within 3 months or has had stimulator adjustments in the previous 2 weeks
- History of a psychotic disorder prior to PD, including bipolar disorder, schizophrenia, schizoaffective disorder, and major depressive disorder with psychotic features, if it is thought to be the cause of the current...
- Suspected atypical parkinsonian disorder or dementia with Lewy bodies (DLB)
- Psychosis secondary to other toxic or metabolic disorder
- History of long QT syndrome
- Documented chart evidence indicating persistent hypoglycemia, hypokalemia, hypomagnesemia that would put patient at increased risk for QTc prolongation.
- History of ventricular arrhythmias, except when treated with an implantable cardioverter defibrillator (ICD) or pacemaker, or untreated or unstable atrial fibrillation/flutter
- Currently taking medications that are moderate or strong CYP3A4 inducers or strong CYP3A4 inhibitors
- Concomitant use of drugs that prolong the QTc interval with a known risk of Torsades de Pointes
- Comorbid medical condition determined too severe by Site Investigator to allow participation in clinical trial
- Failure to tolerate quetiapine or pimavanserin previously
- Severe cognitive impairment (MoCA score \<5)
- Nursing home placement at screening or planned placement during the study, unless approved by study Co-Chairs. Approval will depend upon nursing facility agreement to receive, return, and administer medications or allow...
- Currently enrolled in another therapeutic or treatment study
- Pregnant, or a female of child-bearing potential who is unwilling to use a reliable form of contraception
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Loma Linda, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- West Los Angeles, California, United States
- Aurora, Colorado, United States
- Gainesville, Florida, United States
- Hines, Illinois, United States
- Lexington, Kentucky, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Albuquerque, New Mexico, United States
- Syracuse, New York, United States
- Asheville, North Carolina, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Loma Linda, California, United States; Palo Alto, California, United States; San Francisco, California, United States; West Los Angeles, California, United States; Aurora, Colorado, United States and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.