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dimethyl fumarate · ASSURE

Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis

Ensayo de BIOGEN INC. en esclerosis multiple recurrente-remitente.

Más ensayos de: Esclerosis múltiple remitente-recurrente.

Fase

Fase 4

Estado

Completado

Participantes

241

previstos

Centros

21

Fin del objetivo primario

feb 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en may 2014.

Qué mide

Porcentaje de participantes que reportan eventos de enrojecimiento general durante las primeras 4 semanas de tratamiento, evaluados por la Modified Global Flushing Severity Scale (MGFSS) (del dia 2 a la semana 4)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin (acetylsalicylic acid \[ASA\]) taken twice a day (BID) with dimethyl fumarate (DMF) administration or 75 mg enteric-coated ASA taken once daily in the morning (QAM) with DMF administration reduces the incidence and/or severity of flushing events in subjects with relapsing-remitting multiple sclerosis (RRMS) compared with ASA-placebo administered with DMF in the clinical practice setting. Secondary objectives of this study are: to evaluate the safety and tolerability of DMF administered with and without enteric-coated ASA in the clinical practice setting; to evaluate the impact of DMF administration on quality of life as measured by the Short Form 36 (SF-36®) and European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L) questionnaires.

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02090413), actualizada en nov 2016.