Clinical trial
A 12-week, Multicenter, Active-treatment Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Name
331-201-00182
Description
Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type (AAD).
Trial arms
Trial start
2018-10-11
Estimated PCD
2022-09-19
Trial end
2022-09-19
Status
Completed
Phase
Early phase I
Treatment
Brexpiprazole
2 or 3 mg tablet
Arms:
Prior Brexpiprazole
Brexpiprazole
0.5 to 3 mg tablet
Arms:
Prior Placebo
Size
259
Primary endpoint
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity
From first dose through 30 days after last dose of study drug (Up to approximately Week 16)
Eligibility criteria
Inclusion Criteria:
* Participants must have participated in the 331-14-213 study.
* Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior.
Exclusion Criteria:
* Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 259, 'type': 'ACTUAL'}}
Updated at
2023-11-14
1 organization
1 product
1 indication
Product
BrexpiprazoleIndication
Alzheimer's Disease