At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 270 enrolled
Drug / intervention
Brexpiprazole, OPC-34712drug
Likely dose
Brexpiprazole, OPC-34712 2 mgfrom 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 Flexible Dosing 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 Aug 14, 2013·Updated Nov 20, 2020
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole, OPC-34712 for Agitation Associated With and 4 related conditions. Completed, enrolled 270 participants across 70 sites in 9 countries.
Detailed Summary
To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects 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
CountriesBulgaria, Canada, Finland, France, Russia, Slovenia, Ukraine, United Kingdom, United States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 2013
Enrollment StartSep 2013
Primary CompletionMar 2017
TodayJul 2026
First PostedAug 14, 2013
Enrollment StartSep 1, 2013
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 12.9 years ago
Interventions
Brexpiprazole, OPC-34712drug
Flexible dose of 0.5 to 2 mg/day or placebo tablets for up to 12 weeks