Schizophrenia
Conditions
Keywords
acute schizophrenia,, exacerbated acute schizophrenia
Brief summary
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.
Detailed description
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
Interventions
DRUGLB-102 (50 mg tablet)
LB-102 oral tablet given for six weeks
DRUGLB-102 (100 mg tablet)
LB-102 oral tablet given for six weeks
OTHERPlacebo
Placebo tablet given orally for six weeks
Sponsors
LB Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Patients will be randomized 1:1:1 to one of three treatments
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Able to provide ICF * Willing to be hospitalized for duration of the study * Diagnosis of schizophrenia as defined by DSM-5 * BMI - 18-40 * PANSS 80-120
Exclusion criteria
* 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 * DSM-5 diagnosis other than schizophrenia * Risk of suicidal behavior * Risk of violent or destructive behavior * Clinically significant tardive dyskinesia determined by a score of ≥3 on Item 8 of the AIMS at Screening * Score of ≥3 on the BARS global clinical assessment of akathisia at Screening * Insulin dependent diabetes * Known ischemic heart disease or any history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery * History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to Week 6 on the Positive and Negative Syndrome Scale | 6 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Safety and Tolerability of LB-102 | 10 weeks | Evaluate the safety and tolerability of LB-102 in patients by evaluating adverse events |
| Change in Clinical Global Impressions-Severity of Illness scale (CGI-S) | 6 weeks | 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 |
Countries
United States
Contacts
CONTACTBranislav Mancevski, MD
Outcome results
None listed