A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Antipsychotic Efficacy and Safety of LB 102 in the Treatment of Adult Patients With Acute Schizophrenia
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Pillar Clinical Research
RECRUITING
Bentonville
Pillar Clinical Research
RECRUITING
Little Rock
Woodland International Research Group
RECRUITING
Little Rock
California
ProScience Research Group
RECRUITING
Culver City
CenExel
RECRUITING
Garden Grove
Synergy San Diego
RECRUITING
Lemon Grove
Clinical Innovations, Inc.
RECRUITING
Riverside
Florida
Health Synergy Clinical Research
RECRUITING
Boynton Beach
Innovative Clinical Research
RECRUITING
Miami Lakes
Georgia
Accelerated Clinical Trial
RECRUITING
Snellville
Illinois
Pillar Clinical Research
RECRUITING
Chicago
Missouri
Arch Clinical Trials
RECRUITING
St Louis
Ohio
Neuro-Behavioral Clinical Research
RECRUITING
North Canton
Contact Information
Primary
Anna Eramo, MD
clinicaltrials@lbpharma.us
212-605-0300
Backup
Branislav Mancevski, MD
clinicaltrials@lbpharma.us
212-605-0300
Time Frame
Start Date: 2026-03-25
Estimated Completion Date: 2027-10
Participants
Target number of participants: 456
Treatments
Experimental: LB-102 (50 mg tablet)
• LB-102 50 mg given orally for 6 weeks
Experimental: LB-102 (100 mg tablet)
LB-102 100 mg given orally for 6 weeks
Placebo_comparator: Placebo
Placebo given orally for 6 weeks
Related Therapeutic Areas
Sponsors
Leads: LB Pharmaceuticals Inc.