NCT03893825

A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia

A Study to Evaluate the Safety, Tolerability, and Effect 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: 336 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 13 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the long-term safety and tolerability of TV-46000. The primary safety and tolerability endpoint is the frequency of all adverse events, including serious adverse events. For new participants, the total duration of participant participation in the study is planned to be up to 80 weeks (including a screening period of up to 4 weeks, a 12-week oral conversion/stabilization stage \[Stage 1\], a 56-week double-blind maintenance stage \[Stage 2\], and a follow-up period \[8 weeks\]). For roll-over participants, the total duration of participant participation in the study is planned to be up to 64 weeks (including up to 56 weeks in the maintenance stage \[Stage 2\] and a follow-up period \[8 weeks\]). Participants who started Stage 2 who relapse or meet 1 or more of the withdrawal criteria should be invited to perform the Early Termination visit as soon as possible within 4 weeks of the last injection. Participants who withdraw from the study before completing the 56-week maintenance stage will have follow-up procedures and assessments performed at their follow-up visits. During the follow-up period, participants will be treated according to the investigator's judgment. All participants will be treated with active drug.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	TV-46000	TV-46000 will be administered per dose and schedule specified in the arm description.
DRUG	Placebo	Placebo matching to TV-46000 will be administered per schedule specified in the arm description.

Timeline

• Start date: 2019-04-17
• Primary completion: 2021-12-02
• Completion: 2021-12-02
• First posted: 2019-03-28
• Last updated: 2022-12-07
• Results posted: 2022-10-04

Locations

90 sites across 5 countries: United States, Bulgaria, Canada, France, Israel

Regulatory

• FDA-regulated drug study