A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia
Status:
Active, not recruiting
Trial end date:
2021-12-14
Target enrollment:
Participant gender:
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 patients, the total duration of patient
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
patients, the total duration of patient 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]). Patients 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. Patients 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, patients will be treated according to the
investigator's judgment.
All subjects will be treated with active drug.
Phase:
Phase 3
Details
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc. Teva Branded Pharmaceutical Products, R&D Inc.