Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLB Pharmaceuticals Inc.
About this trial
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 criteria
Qualifiers
Able to provide ICF
Willing to be hospitalized for duration of the study
Diagnosis of schizophrenia as defined by DSM-5
BMI - 18-40
Disqualifiers
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
Trial design
Treatments tested in this trial
- LB-102 (50 mg tablet)
- LB-102 (100 mg tablet)
- Placebo
Treatment groups
456 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov