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TV-44749 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 days 57 to 84

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 57 to 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 57 to 84

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 57 to 84 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC of oral olanzapine

Area under the curve (AUC) of TV-44749

Secondary outcome measures

Cmax,ss of oral olanzapine

Cmin,ss of oral olanzapine

Maximum observed plasma drug concentration at steady state (Cmax,ss) of TV-44749

+4 more

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897

38%

sedation

25%

headache

13%

phosphenes

13%

hypomania

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine and DCS Treatment

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TV-44749Experimental Treatment1 Intervention

Group II: Oral olanzapineActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor

251 Previous Clinical Trials

3,485,260 Total Patients Enrolled

5 Trials studying Schizophrenia

1,651 Patients Enrolled for Schizophrenia

Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.

93 Previous Clinical Trials

38,663 Total Patients Enrolled

5 Trials studying Schizophrenia

1,651 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 60 and above eligible for participation in this study?

"This research study is seeking individuals over 18 years of age but below the age of 64 to participate."

Answered by AI

Are multiple medical facilities within the United States involved in conducting this trial?

"Patients are presently being enrolled at multiple Teva Investigational Sites, such as Site 15740 in Torrance, Florida; Site 15738 in Hollywood, Georgia; and Site 15741 in Atlanta, New jersey among an additional half-dozen locations."

Answered by AI

What is the current total number of participants being recruited for this clinical study?

"Affirmative. The details on clinicaltrials.gov reveal that this medical investigation is actively seeking participants. Initially shared on March 20th, 2024, and most recently updated on April 1st, 2024, the trial aims to enroll a total of 116 patients across six designated facilities."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"Affirmative. Information from clinicaltrials.gov indicates that this investigation is presently in search of participants. Initially shared on March 20, 2024, with the latest revision made on April 1, 2024, recruitment aims to include a total of 116 individuals spread across six distinct venues."

Answered by AI

What are the risks associated with administering TV-44749 to individuals?

"Based on the stage of this study, which is Phase 1 with limited safety and efficacy data available, TV-44749 has been assigned a safety rating of 1 by our team at Power."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia

2024. "An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06315283.

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