Trials / Completed
CompletedNCT03503318
Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult and Adolescent Patients With Schizophrenia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 544 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 13 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy, safety, and tolerability of different dose regimens of TV-46000 administered subcutaneously (SC) as compared to placebo during maintenance treatment in adult and adolescent participants with schizophrenia. The study will include male and female participants, 13 to 65 years of age, who have a confirmed diagnosis of schizophrenia, are clinically stable, and are eligible for risperidone treatment
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TV-46000 | TV-46000 will be administered per dose and schedule specified in the arm. |
| DRUG | Placebo | Placebo matching to TV-46000 will be administered per schedule specified in the arm. |
Timeline
- Start date
- 2018-04-27
- Primary completion
- 2020-09-30
- Completion
- 2020-12-03
- First posted
- 2018-04-19
- Last updated
- 2023-03-10
- Results posted
- 2021-12-09
Locations
81 sites across 2 countries: United States, Bulgaria
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03503318. Inclusion in this directory is not an endorsement.