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New treatment option for Schizophrenia
Official title Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia
ClinicalTrials.gov ID: NCT07363577
What this study is testing
What is LB-102 (50 mg tablet)?
LB-102 (50 mg tablet) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for schizophrenia.
Also referred to as LB-102.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, study designed to evaluate the efficacy, safety, tolerability, and of LB-102 versus placebo for the treatment of adult patients with an acute exacerbation of schizophrenia.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Able to provide ICF
- Willing to be hospitalized for duration of the study
- Diagnosis of schizophrenia as defined by DSM-5
- BMI - 18-40
- PANSS 80-120
You likely can't join if
- Sexually active m/f not willing to adhere to highly effect birth control
- Breast feeding
- Increase in PANSS of \> 20% between screening and baseline
- History of resistant treatment to schizophrenia medications
- DSM-5 diagnosis other than schizophrenia
- Risk of suicidal behavior
See the full eligibility criteria
- Able to provide ICF
- Willing to be hospitalized for duration of the study
- Diagnosis of schizophrenia as defined by DSM-5
- BMI - 18-40
- PANSS 80-120
- Sexually active m/f not willing to adhere to highly effect birth control
- Breast feeding
- Increase in PANSS of \> 20% between screening and baseline
- History of resistant treatment to schizophrenia medications
- DSM-5 diagnosis other than schizophrenia
- Risk of suicidal behavior
- Risk of violent or destructive behavior
- Clinically significant tardive dyskinesia determined by a score of ≥3 on Item 8 of the AIMS at Screening
- Score of ≥3 on the BARS global clinical assessment of akathisia at Screening
- Insulin dependent diabetes
- Known ischemic heart disease or any history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that...
The study team makes the final eligibility decision.
Where it's taking place
- Bentonville, Arkansas, United States
- Little Rock, Arkansas, United States
- Culver City, California, United States
- Garden Grove, California, United States
- Lemon Grove, California, United States
- Riverside, California, United States
- Boynton Beach, Florida, United States
- Miami Lakes, Florida, United States
- Snellville, Georgia, United States
- Chicago, Illinois, United States
- St Louis, Missouri, United States
- North Canton, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bentonville, Arkansas, United States; Little Rock, Arkansas, United States; Culver City, California, United States; Garden Grove, California, United States; Lemon Grove, California, United States; Riverside, California, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.