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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 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.

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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.

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

FieldValue
Enrollment Target 675 participants
Start Date 2023-01-24
Est. Completion 2025-01-27
Phase Phase 3

What the Registry Record Tells You About NCT05693935

The ClinicalTrials.gov registry entry for NCT05693935 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 675 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (211% higher). The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.