drugset / Trial / NCT02730455

Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke

NCT02730455

Phase 2 Completed 277 enrolled Biogen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to assess the clinical effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of functional independence and activities of daily living. The secondary objective of the study is to explore dose and exposure response and the clinical treatment effects of natalizumab versus placebo in acute ischemic stroke on the following: measures of independence, activities of daily living, neurologic function, quality of life, cognition, and safety and tolerability

Timeline

Start
2016-07-18
Primary completion
2017-11-20
Completion
2017-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject natalizumab Monoclonal antibody 300 mg Intravenous
Subject natalizumab Monoclonal antibody 600 mg Intravenous

Indications