NCT02730455

Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke

Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) in Acute Ischemic Stroke

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 277 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	natalizumab	Administered as specified in the treatment arm
DRUG	Placebo	Matched placebo

Timeline

• Start date: 2016-07-18
• Primary completion: 2017-11-20
• Completion: 2017-11-20
• First posted: 2016-04-06
• Last updated: 2019-01-08
• Results posted: 2019-01-08

Locations

53 sites across 4 countries: United States, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study