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CYP-1020 · CLARITY

Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia

Ensayo de BioLineRx Ltd. en Esquizofrenia · Efecto cognitivo en pacientes esquizofrenicos.

Más ensayos de: Esquizofrenia.

Fase

Fase 2/3

Estado

Interrumpido

Participantes

269

previstos

Centros

39

Fin del objetivo primario

mar 2013

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en may 2011.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «pre-planned interim analysis of the Phase II/III CLARITY trial of BL-1020 indicate that the trial would not meet the pre-specified primary efficacy endpoint.».

Qué mide

Cognicion (inicio y 6 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a randomized, double-blind, active-controlled, 6 month study designed to evaluate the cognitive effects of treatment with CYP-1020 compared to risperidone. The primary efficacy endpoint will occur after 6 weeks of treatment; additional (secondary) efficacy endpoints will occur after 12 and 24 weeks of treatment. Up to 450 patients will be randomized to CYP-1020 or risperidone in a 1:1 ratio. The study will utilize a flexible dose escalation scheme designed to allow patients to titrate to their maximally tolerated dose; doses of CYP-1020 may range from a minimum of 15 mg to a maximum of 35 mg, whereas doses of risperidone will range from a minimum of 1 mg to 3 mg BID (2-6 mg daily). To ensure effective blinding across all treatment groups, all patients will be treated twice daily with study drug and/or placebo, as indicated (i.e., double-dummy design).

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Ficha completa en ClinicalTrials.gov (NCT01363349), actualizada en sep 2014.