Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis
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|ClinicalTrials.gov Identifier: NCT03325556|
Recruitment Status : Completed
First Posted : October 30, 2017
Results First Posted : June 21, 2021
Last Update Posted : June 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Dementia-related Psychosis||Drug: Placebo Drug: Pimavanserin 34 mg Drug: Pimavanserin 20 mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||392 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis|
|Actual Study Start Date :||September 27, 2017|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||October 30, 2019|
|Placebo Comparator: Placebo||
Placebo, tablets, once daily by mouth
|Experimental: Drug - Pimavanserin||
Drug: Pimavanserin 34 mg
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth
Drug: Pimavanserin 20 mg
Pimavanserin 20 mg total daily dose, tablets, once daily by mouth
- Time From Randomization to Relapse in the Double-blind (DB) Period [ Time Frame: From randomization in the DB period through 26 weeks ]
The time from randomization to relapse in the DB period was compared between treatment groups using a Cox regression model. The treatment effect was measured by the hazard ratio (HR).
Relapse was defined as (1) ≥30% increase in SAPS-H+D total score from DB baseline (BL) and CGI-I score ≥6 relative to DB BL, (2) treatment with antipsychotic for dementia-related delusions/hallucinations, (3) treatment/study discontinuation due to lack of efficacy, and/or (4) hospitalization for worsening dementia-related psychosis.
SAPS-H+D is a 20-item scale; the total score is the sum of the 20 item scores (range 0-100); higher scores denote more severe symptoms. CGI-I is a clinician-rated 7-point scale to rate improvement in hallucinations/delusions relative to BL (range 1-7); higher scores denote less improvement or worsening.
A pre-specified IA was conducted after accrual of 40 adjudicated relapse events. The prespecified stopping criterion was met; the study was stopped for efficacy.
- Time From Randomization to Discontinuation From the DB Period for Any Reason [ Time Frame: From randomization in the DB period through 26 weeks ]The endpoint of time from randomization to discontinuation from the DB period for any reason (other than termination of the study by the sponsor) was compared between treatment groups using a Cox regression model. The treatment effect was measured by the HR.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325556