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TV-44749 vs Oral Olanzapine for Schizophrenia

Phase 1
Recruiting
Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare how well TV-44749 works when given as a shot under the skin versus when taken as a pill (ZYPREXA®) in people with schizophrenia. It will also

Who is the study for?
This trial is for adults with stable schizophrenia, currently on a steady dose of oral olanzapine. Men must be sterile or use birth control, and women should be non-pregnant, postmenopausal, or using contraception. Participants must maintain their smoking status throughout the study.
What is being tested?
The trial is testing TV-44749 given by injection compared to oral olanzapine to see how the body absorbs it in people with schizophrenia. It will also assess safety and measure other drug levels over approximately 21 weeks.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to TV-44749 or oral olanzapine as part of evaluating the treatment's safety and tolerability.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897
38%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS Treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TV-44749Experimental Treatment1 Intervention
Group II: Oral olanzapineActive Control1 Intervention

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Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
256 Previous Clinical Trials
3,486,348 Total Patients Enrolled
5 Trials studying Schizophrenia
1,686 Patients Enrolled for Schizophrenia
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
97 Previous Clinical Trials
39,561 Total Patients Enrolled
5 Trials studying Schizophrenia
1,686 Patients Enrolled for Schizophrenia
~29 spots leftby Apr 2025
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