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TV-44749 for Schizophrenia (SOLARIS Trial)

Phase 3
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
The participant has a current confirmed diagnosis of schizophrenia according to the DSM-5, for >1 year
The participant has exacerbation of schizophrenia that started ≤8 weeks prior to screening and would benefit from psychiatric hospitalization or continued hospitalization for symptoms of schizophrenia.
Must not have
The participant has a known history of the following: (a) borderline personality disorder, antisocial personality disorder, or bipolar disorder; (b) traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's disease, or another form of dementia, or any chronic organic disease of the central nervous system; and (c) intellectual disability of a severity that would impact ability to participate in the study.
The participant was hospitalized for >14 days (with the exception of social or administrative hospitalization) in the current exacerbation episode prior to screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8 to week 60
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new medication called TV-44749 to see if it helps adults with schizophrenia, especially those with worsening symptoms. The medication likely works by balancing brain chemicals to reduce symptoms. The study will last over a year, with different phases to test both its effectiveness and safety.

Who is the study for?
Adults with recent schizophrenia flare-ups, a BMI of 18-40, and diagnosed over a year ago can join. Women must not plan pregnancy and use contraception. Excluded are those hospitalized for over 14 days recently, at risk of violence or suicide, on certain antipsychotics or treatments like clozapine in the past year, have significant other mental health diagnoses or substance abuse issues.
What is being tested?
The trial tests TV-44749's effectiveness in adults with schizophrenia across three different doses compared to a placebo. It assesses improvement from baseline to week 56 with weekly then monthly check-ins.
What are the potential side effects?
While specific side effects aren't listed here, common ones for antipsychotic medications include drowsiness, weight gain, dry mouth, restlessness and sometimes more serious effects like movement disorders or metabolic changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with schizophrenia for over a year.
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My schizophrenia symptoms worsened in the last 8 weeks, needing hospital care.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe mental health issues, significant brain injuries, Alzheimer's, other dementias, or intellectual disabilities that would affect my study participation.
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I was in the hospital for more than 14 days due to my current health issue, not for social or administrative reasons.
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I am currently on long-acting injectable antipsychotics.
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I am taking more than 20 mg of olanzapine daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8 to week 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 to week 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline to week 8 in the Positive and Negative Syndrome Scale (PANSS) total score
Secondary study objectives
Change from Baseline in Abnormal Involuntary Movement Scale (AIMS) total score
Change from Baseline in total score in Abnormal Involuntary Movement Scale (AIMS)
Change from baseline in Barnes Akathisia Rating Scale (BARS) total score
+16 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: TV-44749 - Dose level 3Experimental Treatment1 Intervention
High dose regimen
Group II: TV-44749 - Dose level 2Experimental Treatment1 Intervention
Medium dose regimen
Group III: TV-44749 - Dose level 1Experimental Treatment1 Intervention
Low dose regimen
Group IV: PlaceboPlacebo Group1 Intervention
Matching Placebo

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Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
256 Previous Clinical Trials
3,485,932 Total Patients Enrolled
5 Trials studying Schizophrenia
1,127 Patients Enrolled for Schizophrenia
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
97 Previous Clinical Trials
39,145 Total Patients Enrolled
5 Trials studying Schizophrenia
1,127 Patients Enrolled for Schizophrenia

Media Library

TV-44749 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05693935 — Phase 3
Schizophrenia Research Study Groups: TV-44749 - Dose level 1, TV-44749 - Dose level 2, TV-44749 - Dose level 3, Placebo
Schizophrenia Clinical Trial 2023: TV-44749 Highlights & Side Effects. Trial Name: NCT05693935 — Phase 3
TV-44749 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05693935 — Phase 3
Schizophrenia Patient Testimony for trial: Trial Name: NCT05693935 — Phase 3
~233 spots leftby Nov 2025
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