52-week Open Label Safety-Tolerability Study

ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLB Pharmaceuticals Inc.

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • LB-102

    Drug

    LB-102 flexible dosing 50 mg - 100 mg

Treatment groups

900 Participants
are divided into 1 treatment group
Group A: LB-102Other 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
52 weeks

Secondary outcomes

1

Evaluate long term safety and tolerability

Evaluating the safety of treatment by number of adverse events

Time frame
52 weeks
2

Evaluate long term safety and tolerability

Evaluating the safety of treatment by change in vital signs, electrocardiogram (QTC), and weight/height for BMI

Time frame
52 weeks
3

Evaluate long term safety and tolerability

Evaluating the safety of treatment by conducting physical examinations

Time frame
52 weeks
4

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.

Time frame
52 weeks

Other outcomes

Sponsors and contacts

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