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.
This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, multicenter study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of LB-102 100 mg once daily (QD) and LB-102 50 mg QD versus placebo QD for the treatment of adult patients with an acute exacerbation of schizophrenia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
456
LB-102 oral tablet given for six weeks
LB-102 oral tablet given for six weeks
Placebo tablet given orally for six weeks
Pillar Clinical Research
Bentonville, Arkansas, United States
RECRUITINGPillar Clinical Research
Little Rock, Arkansas, United States
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
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
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
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Woodland International Research Group
Little Rock, Arkansas, United States
RECRUITINGProScience Research Group
Culver City, California, United States
RECRUITINGCenExel
Garden Grove, California, United States
RECRUITINGSynergy San Diego
Lemon Grove, California, United States
RECRUITINGClinical Innovations, Inc.
Riverside, California, United States
RECRUITINGHealth Synergy Clinical Research
Boynton Beach, Florida, United States
RECRUITINGInnovative Clinical Research
Miami Lakes, Florida, United States
RECRUITINGAccelerated Clinical Trial
Snellville, Georgia, United States
RECRUITING...and 3 more locations