Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia
NCT07363577 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 456
Last updated 2026-05-06
Summary
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.
Conditions
Interventions
- DRUG
-
LB-102 (50 mg tablet)
LB-102 oral tablet given for six weeks
- DRUG
-
LB-102 (100 mg tablet)
LB-102 oral tablet given for six weeks
- OTHER
-
Placebo
Placebo tablet given orally for six weeks
Sponsors & Collaborators
-
LB Pharmaceuticals Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-25
- Primary Completion
- 2027-06-30
- Completion
- 2027-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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