At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 433 enrolled
Drug / intervention
Brexpiprazole, OPC-34712 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted May 24, 2013·Updated Dec 31, 2020
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole, OPC-34712 and Placebo Oral Tablet for Agitation Associated With and 4 related conditions. Completed, enrolled 433 participants across 85 sites in 7 countries.
Detailed Summary
To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAgitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases
CountriesCroatia, Germany, Russia, Serbia, Spain, Ukraine, United States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartJul 2013
Primary CompletionMar 2017
TodayJul 2026
First PostedMay 24, 2013
Enrollment StartJul 11, 2013
Primary CompletionMar 15, 2017
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.1 years ago
Interventions
Brexpiprazole, OPC-34712drug
Once-daily, tablets
Placebo Oral Tabletdrug
Once-daily, tablets