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NCT05693935 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label, Long-Term Safety Phase to Evaluate the Efficacy and Safety of TV-44749 in Adults With Schizophrenia
A Phase 3 study of Schizophrenia, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 675
- Enrollment target
- 20
- Study locations
NCT05693935: Completed Phase 3 study of Schizophrenia, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT05693935 is a Phase 3 study of Schizophrenia that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 675 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (211% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05693935, a Phase 3 study of Schizophrenia, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 675 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to evaluate the efficacy of TV-44749 in adult participants with schizophrenia. A key secondary objective is to further evaluate the efficacy of TV-44749 based on additional parameters in adult participants with schizophrenia. A secondary objective is to evaluate the safety and tolerability of TV-44749 in adult participants with schizophrenia Another secondary objective of this study is to evaluate the efficacy of TV-44749 from baseline to endpoint in Period 1 in adult participants with schizophrenia. Total study duration is up to 61 weeks, and treatment duration is up to 56 weeks, with weekly visits during the first 8 weeks and then monthly in-clinic visits with weekly calls during the remainder of the treatment period.
Primary Outcome
The PANSS is a 30-item scale used to evaluate positive and negative symptoms of schizophrenia. The PANSS was used to identify the presence and severity of psychopathology symptoms, the relationship of these symptoms to one another, and the global psychopathology. Each item was scored on a 7-point scale ranging from 1 (absent) to 7 (extreme). The positive symptom scale includes 7 items with a maximum score of 49; the negative symptom scale includes 7 items with a maximum score of 49; and the gene
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TV-44749
Study Locations (20)
California
- Teva Investigational Site 15470 - Anaheim
- Teva Investigational Site 15459 - Bellflower
- Teva Investigational Site 15490 - Garden Grove
- Teva Investigational Site 15474 - La Habra
- Teva Investigational Site 15481 - Lemon Grove
- Teva Investigational Site 15491 - Long Beach
- Teva Investigational Site 15497 - Los Angeles
- Teva Investigational Site 15482 - Los Angeles
- Teva Investigational Site 15450 - Orange
- Teva Investigational Site 15455 - Pico Rivera
- Teva Investigational Site 15471 - Riverside
- Teva Investigational Site 15444 - San Diego
- Teva Investigational Site 15449 - Santee
- Teva Investigational Site 15461 - Sherman Oaks
- Teva Investigational Site 15483 - Torrance
Arkansas
- Teva Investigational Site 15460 - Bentonville
- Teva Investigational Site 15465 - Little Rock
- Teva Investigational Site 15453 - Rogers
Florida
- Teva Investigational Site 15457 - Hialeah
- Teva Investigational Site 15488 - Hollywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 675 participants |
| Start Date | 2023-01-24 |
| Est. Completion | 2025-01-27 |
| Phase | Phase 3 |
What the finished NCT05693935 record still lists
NCT05693935 is an interventional study that assigns participants to a tested intervention. The registered 675 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (211% higher).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05693935 names 20 study sites across 3 states, led by California, Arkansas, Florida.
Frequently Asked Questions
What is clinical trial NCT05693935 about?
NCT05693935 is a clinical study titled "A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label, Long-Term Safety Phase to Evaluate the Efficacy and Safety of TV-44749 in Adults With Schizophrenia". The primary objective of this study is to evaluate the efficacy of TV-44749 in adult participants with schizophrenia. A key secondary objective is to further evaluate the efficacy of TV-44749 based on additional parameters in adult participants with schizophrenia. A secondary objective is to evalu...
What is the current status of trial NCT05693935?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 675 participants. The study started on 2023-01-24. Estimated completion is 2025-01-27.
What conditions does trial NCT05693935 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT05693935?
The interventions under investigation include: Placebo (DRUG), TV-44749 (DRUG).
Who is sponsoring clinical trial NCT05693935?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05693935 being conducted?
This trial has 20 study locations across Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05693935's enrollment target sits among peer trials
675 21st of 315 higher than 295 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia 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.
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