Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia
Recruiting
Phase 3
Interventional Study
Schizophrenia
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 456 (estimated)
- Sponsor
- LB Pharmaceuticals Inc. · Industry
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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.
Trial Locations
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Eligibility Criteria
Inclusion 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
Exclusion Criteria:
* Sexually active m/f not willing to adhere to highly effect birth control
* Breast feeding
* Increase…
Contacts