Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • LB-102 (50 mg tablet)

    Drug

    LB-102 oral tablet given for six weeks

  • LB-102 (100 mg tablet)

    Drug

    LB-102 oral tablet given for six weeks

  • Placebo

    Other intervention

    Placebo tablet given orally for six weeks

Treatment groups

456 Participants
are divided into 3 treatment groups
Group A: LB-102 (50 mg tablet)Experimental treatment 1 intervention
Group B: LB-102 (100 mg tablet)Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline to Week 6 on the Positive and Negative Syndrome Scale

Determine whether LB-102, demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo: increase in scale indicates worsening while a decrease in the scale likely indicates a response to treatment

Time frame
6 weeks

Secondary outcomes

1

Evaluate the Safety and Tolerability of LB-102

Evaluate the safety and tolerability of LB-102 in patients by evaluating adverse events

Time frame
10 weeks
2

Change in Clinical Global Impressions-Severity of Illness scale (CGI-S)

Assess the effect of LB-102 on the treatment for schizophrenia, as determined by a change from Baseline in the Clinical Global Impressions Severity of Illness scale: whereas increase demonstrates worsening of illness and decrease in score likely indicates response to treatment

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LB Pharmaceuticals Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now