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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provide ICF
Patients clinically stable PANSS </= 80 at screening
CGI-S </+ 3 at screening
Medically stable
Disqualifiers
Sexually active M/F patients not willing to use highly effective contraception
Breast feeding
History of treatment resistance to schizophrenia medications
DSM-5 current diagnosis other than schizophrenia
Trial design
Single group
Treatments tested in this trial
LB-102
DrugLB-102 flexible dosing 50 mg - 100 mg
Treatment groups
Trial outcomes
Primary outcomes
Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events.
Overall adverse events, serious adverse events, incidence of treatment emergent events and adverse events which lead to study discontinuation
Secondary outcomes
Evaluate long term safety and tolerability
Evaluating the safety of treatment by number of adverse events
Evaluate long term safety and tolerability
Evaluating the safety of treatment by change in vital signs, electrocardiogram (QTC), and weight/height for BMI
Evaluate long term safety and tolerability
Evaluating the safety of treatment by conducting physical examinations
Assess the long-term effectiveness determined by Positive and Negative Syndrome Scale (PANSS)
Change in Positive and Negative Syndrome Scale (PANSS) from Baseline to end of treatment where a decrease in score likely indicate response to treatment whereas an increase in score may indicate a worsening of disease where an increase in the scale score may indicate a worsening of disease and decrease in score likely indicates response to treatment.
Sponsors and contacts
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