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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LB-102 (50 mg tablet) | Experimental | • LB-102 50 mg given orally for 6 weeks |
|
| LB-102 (100 mg tablet) | Experimental | LB-102 100 mg given orally for 6 weeks |
|
| Placebo | Placebo Comparator | Placebo given orally for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LB-102 (50 mg tablet) | Drug | LB-102 oral tablet given for six weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Safety and Tolerability of LB-102 | Evaluate the safety and tolerability of LB-102 in patients by evaluating adverse events | 10 weeks |
| Change in Clinical Global Impressions-Severity of Illness scale (CGI-S) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Eramo, MD | Contact | 212-605-0300 | clinicaltrials@lbpharma.us | |
| Branislav Mancevski, MD | Contact | 212-605-0300 | clinicaltrials@lbpharma.us |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pillar Clinical Research | Recruiting | Bentonville | Arkansas | 72712 | United States |
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Patients will be randomized 1:1:1 to one of three treatments
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| LB-102 (100 mg tablet) | Drug | LB-102 oral tablet given for six weeks |
|
|
| Placebo | Other | Placebo tablet given orally for six 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
| 6 weeks |
| Pillar Clinical Research | Recruiting | Little Rock | Arkansas | 72204 | United States |
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| Woodland International Research Group | Recruiting | Little Rock | Arkansas | 72211 | United States |
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| ProScience Research Group | Recruiting | Culver City | California | 90230 | United States |
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| CenExel | Recruiting | Garden Grove | California | 92845 | United States |
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| Synergy San Diego | Recruiting | Lemon Grove | California | 92064 | United States |
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| Clinical Innovations, Inc. | Recruiting | Riverside | California | 92506 | United States |
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| Health Synergy Clinical Research | Recruiting | Boynton Beach | Florida | 33426 | United States |
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| Innovative Clinical Research | Recruiting | Miami Lakes | Florida | 33016 | United States |
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| Accelerated Clinical Trial | Recruiting | Snellville | Georgia | 30078 | United States |
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| Pillar Clinical Research | Recruiting | Chicago | Illinois | 60641 | United States |
|
| Arch Clinical Trials | Recruiting | St Louis | Missouri | 63141 | United States |
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| Neuro-Behavioral Clinical Research | Recruiting | North Canton | Ohio | 44720 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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