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NCT03503318 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 544
- Enrollment target
NCT03503318: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT03503318 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 544 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03503318, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 544 participants
- Enrollment target
Study 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
Primary Outcome
Relapse was defined as 1 or more of the following items: • Clinical Global Impression-Improvement (CGI-I) of ≥5, and - an increase of any of the 4 Positive and Negative Syndrome Scale (PANSS) items: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content, to a score of \>4 with an absolute increase of ≥2 on specific item since randomization, or - an increase in any of the 4 individual PANSS items to a score of \>4 and an absolute increase of ≥4 on combined
Interventions
- DRUG Placebo
- DRUG TV-46000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 544 participants |
| Start Date | 2018-04-27 |
| Est. Completion | 2020-12-03 |
| Phase | Phase 3 |
What the finished NCT03503318 record still lists
NCT03503318 is an interventional study that assigns participants to a tested intervention. The registered 544 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03503318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03503318 about?
NCT03503318 is a clinical study titled "Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia". 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 p...
What is the current status of trial NCT03503318?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 544 participants. The study started on 2018-04-27. Estimated completion is 2020-12-03.
What interventions are being tested in trial NCT03503318?
The interventions under investigation include: Placebo (DRUG), TV-46000 (DRUG).
Who is sponsoring clinical trial NCT03503318?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03503318's enrollment target sits among peer trials
544 691st of 2000 higher than 1,307 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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