Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia
Purpose
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.
Condition
- Schizophrenia
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Patients will be randomized 1:1:1 to one of three treatments
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental LB-102 (50 mg tablet) |
• LB-102 50 mg given orally for 6 weeks |
|
|
Experimental LB-102 (100 mg tablet) |
LB-102 100 mg given orally for 6 weeks |
|
|
Placebo Comparator Placebo |
Placebo given orally for 6 weeks |
|
Recruiting Locations
Pillar Clinical Research
Bentonville, Arkansas 72712
Bentonville, Arkansas 72712
Pillar Clinical Research
Little Rock, Arkansas 72204
Little Rock, Arkansas 72204
Woodland International Research Group
Little Rock, Arkansas 72211
Little Rock, Arkansas 72211
ProScience Research Group
Culver City, California 90230
Culver City, California 90230
Synergy San Diego
Lemon Grove, California 92064
Lemon Grove, California 92064
Clinical Innovations, Inc.
Riverside, California 92506
Riverside, California 92506
Health Synergy Clinical Research
Boynton Beach, Florida 33426
Boynton Beach, Florida 33426
Innovative Clinical Research
Miami Lakes, Florida 33016
Miami Lakes, Florida 33016
Accelerated Clinical Trial
Snellville, Georgia 30078
Snellville, Georgia 30078
Pillar Clinical Research
Chicago, Illinois 60641
Chicago, Illinois 60641
Arch Clinical Trials
St Louis, Missouri 63141
St Louis, Missouri 63141
Neuro-Behavioral Clinical Research
North Canton, Ohio 44720
North Canton, Ohio 44720
More Details
- Status
- Recruiting
- Sponsor
- LB Pharmaceuticals Inc.
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