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natalizumab · ACTION

Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke

Ensayo de BIOGEN INC. en Acute Ischemic Stroke (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

161

previstos

Centros

50

Fin del objetivo primario

feb 2015

fecha real

Qué significa cada fase y cada estado.

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

Qué mide

Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR]) (del registro, en inglés) (inicio y dia 5)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to determine whether one 300 mg dose of intravenous (IV) natalizumab reduces change in infarct volume from Baseline to Day 5 on magnetic resonance imaging (MRI) in participants with acute ischemic stroke when given at ≤6 hours or at \>6 to ≤9 hours from when they were last known normal (LKN). The secondary objectives of this study in this study population are as follows: to assess the efficacy of natalizumab on change in infarct volume from Baseline to Day 30; to assess efficacy of natalizumab on change in infarct volume from 24 hours to Day 5 and Day 30; to assess the efficacy of natalizumab on clinical measures of stroke outcome; to assess the safety of natalizumab in participants with acute ischemic stroke.

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Ficha completa en ClinicalTrials.gov (NCT01955707), actualizada en may 2016.