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NCT03893825 · ClinicalTrials.gov registry record · Phase 3
A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 336
- Enrollment target
NCT03893825 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 336 participants.
The verdict
NCT03893825, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 336 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG TV-46000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 336 participants |
| Start Date | 2019-04-17 |
| Est. Completion | 2021-12-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03893825
The ClinicalTrials.gov registry entry for NCT03893825 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 336 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03893825 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03893825 about?
NCT03893825 is a clinical study titled "A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia". 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 stu...
What is the current status of trial NCT03893825?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 336 participants. The study started on 2019-04-17. Estimated completion is 2021-12-02.
What interventions are being tested in trial NCT03893825?
The interventions under investigation include: Placebo (DRUG), TV-46000 (DRUG).
Who is sponsoring clinical trial NCT03893825?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
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