| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07369154 | 52-week Open Label Safety-Tolerability Study | PHASE3 | NOT YET_RECRUITING | 900 | — | — | Apr 1, 2026 | Apr 1, 2029 | May 15, 2026 | 23 | United States |
| NCT07363577 | Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia | PHASE3 | RECRUITING | 456 | — | — | Mar 25, 2026 | Oct 1, 2027 | May 6, 2026 | 13 | United States |
| NCT06179108 | Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients With Acute Schizophrenia | PHASE2 | COMPLETED | 359 | — | — | Nov 29, 2023 | Dec 4, 2024 | Oct 22, 2025 | 25 | United States |
| NCT04588129 | Receptor Occupancy of LB-102 Using Positron Emission Tomography (PET) in Healthy Volunteers | PHASE1 | COMPLETED | 16 | — | — | Jan 5, 2021 | Nov 15, 2021 | May 4, 2022 | 1 | United States |
| NCT04187560 | Safety and Tolerability of Single and Multiple Doses of LB-102 in Healthy Adults | PHASE1 | COMPLETED | 64 | — | — | Jan 22, 2020 | Nov 9, 2020 | Dec 10, 2020 | 1 | United States |
Overall adverse events, serious adverse events, incidence of treatment emergent events and adverse events which lead to study discontinuation
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
The Positive and Negative Syndrome Scale (PANSS) is a scale used for measuring symptom severity of patients with schizophrenia. The PANSS rating is composed of 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Patients are scored from 1 to 7 on each symptom scale. The total score of the PANSS is a minimum of 30 and a maximum of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms whereas a higher PANSS total value represents a worse outcome
PET scan of D2/D3 receptor occupancy using raclopride as a tracer
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing.
| Arm | Type | Description |
|---|---|---|
| LB-102 | OTHER | An open label study |
| 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 |
| LB-102, 50 mg QD | EXPERIMENTAL | Oral LB-102: 50 mg (n \~ 105) |
| LB-102, 75 mg QD | EXPERIMENTAL | Oral LB-102: 75 mg (n \~ 105) |
| LB-102, 100 mg | EXPERIMENTAL | Oral LB-102: 100 mg (n \~ 35) |
| Placebo comparator | PLACEBO_COMPARATOR | Drug: Placebo Matched placebo tablets |
| LB-102 50 mg, single dose Cohort 1 | EXPERIMENTAL | LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects. |
| LB-102 100 mg, single dose Cohort 2 | EXPERIMENTAL | LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects. |
| LB-102 75 mg, single dose Cohort 3 | EXPERIMENTAL | LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects. |
| LB-102 100 & 50 mg, multiple dose Cohort 4 | EXPERIMENTAL | LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for four days in 4 subjects: 2 subjects @ 100 mg and 2 subjects @ 50 mg. |
| Part A Cohort 1 | ACTIVE_COMPARATOR | LB-102 50 mg (n=6) or Matching Placebo (n=2) x 1 day |
| Part A Cohort 2 | ACTIVE_COMPARATOR | LB-102 15 mg (n=6) or Matching Placebo (n=2) x 1 day |
| Part A Cohort 3 | ACTIVE_COMPARATOR | LB-102 100 mg (n=6) or Matching Placebo (n=2) x 1 day |
| Part A Cohort 4 | ACTIVE_COMPARATOR | LB-102 200 mg (n=6) or Matching Placebo (n=2) x 1 day |
| Part A Cohort 5 | ACTIVE_COMPARATOR | LB-102 150 mg (n=6) or Matching Placebo (n-2) x 1 day |
| Part B Cohort 6 | ACTIVE_COMPARATOR | LB-102 50 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7) |
| Part B Cohort 7 | ACTIVE_COMPARATOR | LB-102 100 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7) |
| Part B Cohort 8 | ACTIVE_COMPARATOR | LB-102 75 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7) |
| Name | Type | Description |
|---|---|---|
| LB-102 | DRUG | LB-102 flexible dosing 50 mg - 100 mg |
| 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 | Placebo tablet given orally for six weeks |
Inclusion Criteria: * Provide ICF * Patients clinically stable PANSS \</= 70 at screening * CGI-S \</+ 3 at screening * Medically stable * BMI 18 -40 * Taking oral antipsychotic treatment for at least 30 days * Have stable living environment Exclusion Criteria: * Sexually active M/F patients not ...