52-week Open Label Safety-Tolerability Study
Recruiting
Phase 3
Interventional Study
Schizophrenia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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
- 900 (estimated)
- Sponsor
- LB Pharmaceuticals Inc. · Industry
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About This Trial
Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Provide ICF
* Patients clinically stable PANSS \</= 70 at screening
* CGI-S \</+ 3 at screening
* Medically stable
* BMI 18 -40
* Taking oral antipsychotic treatment for at least 30 days
* Have stable living environment
Exclusion Criteria:
* Sexually active M/F patients not …
Contacts