Trials / Completed
CompletedNCT03594123
A 12-week 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
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 259 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 55 Years – 91 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brexpiprazole | 2 or 3 mg tablet |
| DRUG | Brexpiprazole | 0.5 to 3 mg tablet |
Timeline
- Start date
- 2018-10-11
- Primary completion
- 2022-09-19
- Completion
- 2022-09-19
- First posted
- 2018-07-20
- Last updated
- 2023-11-14
- Results posted
- 2023-11-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03594123. Inclusion in this directory is not an endorsement.