Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients With Acute Schizophrenia
Summary
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to evaluate the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. To determine whether LB-102 administered to patients with acutely exacerbated schizophrenia demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo at 28 days. The secondary objectives of the study are to evaluate improvement in CGI-S, safety and tolerability, and pharmacokinetics.
Timeline
- Start
- 2023-11-29
- Primary completion
- 2024-12-04
- Completion
- 2024-12-04
Outcome
Met primary endpoint
paper The trial met the primary end point: LB-102 50 mg and 75 mg, were statistically superior to placebo PMID 42018313 ↗
registry analysis (superiority test); LB-102, 50 mg QD vs Placebo Comparator; p = 0.0009 NCT06179108 ↗
registry analysis (superiority test); LB-102, 75 mg QD vs Placebo Comparator; p = 0.0022 NCT06179108 ↗
Publications
- Background Grattan V, Vaino AR, Prensky Z, Hixon MS. Antipsychotic Benzamides Amisulpride and LB-102 Display Polypharmacy as Racemates, S Enantiomers Engage Receptors D2 and D3, while R Enantiomers Engage 5-HT7. ACS Omega. 2019 Aug 15;4(9):14151-14154. doi: 10.1021/acsomega.9b02144. eCollection 2019 Aug 27.
- Background Biernat L, Grattan VT, Hixon MS, Prensky Z, Vaino AR. A randomized, double-blind, placebo controlled, phase 1 study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of LB-102, a selective dopamine D2/3/5-HT7 inhibitor. Psychopharmacology (Berl). 2022 Sep;239(9):3009-3018. doi: 10.1007/s00213-022-06185-7. Epub 2022 Jul 16.
- Eramo A, Correll CU, Walling DP, Kakar R, Bassani N, Callahan L, Lee BP, Prensky Z, Vaino AR, Kane JM. Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults With Acute Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Apr 22:e260428. doi: 10.1001/jamapsychiatry.2026.0428. Online ahead of print.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LB-102 | Small molecule | 50 mg | Oral |
| Subject | LB-102 | Small molecule | 75 mg | Oral |
| Subject | LB-102 | Small molecule | 100 mg | Oral |