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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8 to week 60
Awards & highlights

SOLARIS Trial Summary

This trial studies the effectiveness of TV-44749 to treat schizophrenia in adults, and assesses its safety and tolerability. Weekly visits for 8 weeks, then monthly with weekly calls. Up to 61 weeks total.

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.Check my eligibility
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.See study design
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.

SOLARIS Trial 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.
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I responded well to antipsychotic treatment, excluding clozapine, in the last year.
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I agree not to become pregnant and will use effective birth control during and 70 days after the study.
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My overall health, including heart and blood tests, is good.

SOLARIS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline to week 8 in the Positive and Negative Syndrome Scale (PANSS) total score
Secondary outcome measures
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

SOLARIS 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

Find a Location

Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
251 Previous Clinical Trials
3,484,736 Total Patients Enrolled
5 Trials studying Schizophrenia
1,127 Patients Enrolled for Schizophrenia
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
93 Previous Clinical Trials
38,131 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

Frequently Asked Questions

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

Can I partake in this medical experiment?

"To participate in this research, individuals with schizophrenia must be aged between 18 and 65. Currently, the team is seeking to enrol up to 640 participants."

Answered by AI

Is enrollment for the trial open to individuals aged 35 or older?

"This particular trial is only open to applicants aged 18-65. For those under the age of 18 and over 65, there are 47 trials and 177 trials respectively catered for them."

Answered by AI

Does this research program have an open enrollment period?

"The information found on clinicaltrials.gov reveals that this research is now recruiting and was originally posted online at the start of January 24th 2023, with its most recent update taking place on February 21st 2023."

Answered by AI

Has the second dosage of TV-44749 obtained regulatory acceptance?

"The safety of TV-44749 - Dose level 2 is rated a 3 due to its Phase 3 status, which indicates that there are multiple rounds of data supporting efficacy and safety."

Answered by AI

What is the geographical scope of this inquiry?

"At the moment, this research is being conducted in 4 distinct sites: Anaheim, Gaithersburg, Dallas and another four. To make participation easier on you it might be best to choose a study site closest to your location so that travel requirements are minimalised."

Answered by AI

What is the current size of the participant pool for this research project?

"To ensure that the research yields meaningful results, Teva Branded Pharmaceutical Products R&D, Inc. must recruit 640 appropriate candidates for this trial from their sites in Anaheim and Gaithersburg."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Teva Investigational Site 15442
Teva Investigational Site 15470
Teva Investigational Site 15486
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have serious mental health problems I need help. Hoping to help others that are diagnosed in the future.
PatientReceived 2+ prior treatments
To help medical fields get better at knowing the best treatment when it comes to mental health.
PatientReceived no prior treatments
I've tried a couple other drugs that don't work as well as intended I'm hoping this will help my symptoms.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Are the visits the same time every time?
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Teva Investigational Site 15468: < 48 hours
  2. Teva Investigational Site 15457: < 48 hours
Typically responds via
Phone Call
~183 spots leftby Oct 2024