Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia

Summary

The objective of the study is to investigate the efficacy, safety and pharmacokinetics of four different doses of BI 425809 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.

Timeline

Start

2016-07-25

Primary completion

2019-12-27

Completion

2020-01-29

Outcome

Met primary endpoint

paper Five of six dose-response models showed a statistically significant benefit of BI 425809 over placebo (linear [t=2·55, p=0·015] PMID 33610228 ↗

paper greater mean improvement from baseline in MCCB overall composite T-score at week 12 with BI 425809 10 mg and 25 mg versus placebo PMID 33610228 ↗

release “BI 425809 met its primary endpoint. The data showed improvement in cognition in stable adult patients with schizophrenia.” prnewswire.com ↗

Publications

• Schultheis C, Rosenbrock H, Mack SR, Vinisko R, Schuelert N, Plano A, Sussmuth SD. Quantitative electroencephalography parameters as neurophysiological biomarkers of schizophrenia-related deficits: A Phase II substudy of patients treated with iclepertin (BI 425809). Transl Psychiatry. 2022 Aug 11;12(1):329. doi: 10.1038/s41398-022-02096-5.
• Fleischhacker WW, Podhorna J, Groschl M, Hake S, Zhao Y, Huang S, Keefe RSE, Desch M, Brenner R, Walling DP, Mantero-Atienza E, Nakagome K, Pollentier S. Efficacy and safety of the novel glycine transporter inhibitor BI 425809 once daily in patients with schizophrenia: a double-blind, randomised, placebo-controlled phase 2 study. Lancet Psychiatry. 2021 Mar;8(3):191-201. doi: 10.1016/S2215-0366(20)30513-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 425809	Unknown	2 mg	Oral
Subject	BI 425809	Unknown	5 mg	Oral
Subject	BI 425809	Unknown	10 mg	Oral
Subject	BI 425809	Unknown	25 mg	Oral

Indications