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dimethyl fumarate · TECNERGY

Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl Fumarate

Ensayo de BIOGEN INC. en Esclerosis múltiple remitente-recurrente · Esclerosis múltiple.

Más ensayos de: Esclerosis múltiple remitente-recurrente · Esclerosis múltiple.

Fase

Fase 4

Estado

Retirado antes de empezar

Fin del objetivo primario

oct 2017

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en jun 2015.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The study was withdrawn for business reasons. The decision to stop the TECNERGY study was not a result of any safety or efficacy concerns.».

Qué mide

Cambio medio desde el valor basal en la fatiga relacionada con la EM según se evalúa por FSMC a los 12 meses en participantes que reciben DMF (12 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of this study is to determine whether dimethyl fumarate (DMF) taken over 12 months is effective in reducing Multiple Sclerosis (MS)-related fatigue, as measured by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are: To investigate changes from Baseline in FSMC and fatigue severity (Fatigue Severity Scale \[FSS\]) at 1, 3, 6, 9, and 12 months in participants receiving DMF; To assess the impact of DMF on patient-reported outcomes (PROs), including work productivity (Work Productivity and Activity Impairment-Multiple Sclerosis questionnaire \[WPAI-MS\]), health-related quality of life (Short Form Health Survey \[SF-12\]), depression (Beck Depression Inventory-Fast Screen \[BDI-FS\]), and sleepiness (Epworth Sleepiness Scale \[ESS\]) at 6 and 12 months in participants receiving DMF; To examine whether an association exists between fatigue and baseline demographics (e.g., age and sex) and disease characteristics (e.g., disease duration, baseline disease activity, treatment history, expanded disability status scale \[EDSS\] score, and PROs); To assess any changes in fatigue-related medication use.

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Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02090348), actualizada en sep 2015.