EU Clinical Trial 2017-002369-23

A phase II randomised, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered BI 409306 during a 28-week treatment period as adjunctive therapy to antipsychotic treatment for the prevention of relapse in patients with schizophrenia.  May 27, 2019

Main objective of the trial: The objective of the study is to investigate the efficacy, safety and tolerability of BI 409306 25mg and 50mg once daily compared with placebo given for 28 weeks in patients with schizophrenia on antipsychotic treatment. The study is designed to show superiority of BI 409306 over placebo in preventing relapse of schizophrenia symptoms. Investigar la eficacia, seguridad y tolerabilidad de BI 409306 25 mg y 50 mg una vez al día, en comparación con placebo, administrado durante 28 semanas en pacientes con esquizofrenia en tratamiento antipsicótico. El estudio está diseñado para demostrar la superioridad de BI 409306 respecto a placebo en la prevención de recaídas de los síntomas de esquizofrenia.

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CA FR JP KR TW US
Keywords
BI 409306 BI 409306 10mg BI 409306 25mg BI 409306 50mg Schizophrenia relapse

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Source:  EMA Last updated:  May 30, 2019

From ClinicalTrialsRegister.eu, a database of the European Medicines Agency. This record may not reflect the most current and accurate data available from the EMA.