101SK202 Acute Ischemic Stroke
Research type
Research Study
Full title
A 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
IRAS ID
204525
Contact name
Roland Veltkamp
Contact email
Sponsor organisation
Biogen Idec Research Ltd
Eudract number
2015-004783-11
Duration of Study in the UK
1 years, 0 months, 28 days
Research summary
This is a phase 2 study to learn more about the safety and effects of different doses of the drug natalizumab in participants with acute ischemic stroke (a blockage in the blood vessels in the brain resulting in cells dying in the surrounding tissue and causing an area of brain damage). It will assess how the different doses of the study drug may affect functional disability, clinical symptoms and the quality of life of people with acute ischemic stroke.
Approximately 240 participants will be randomised (1:1:1) to one of three treatment arms:
• Natalizumab 300 mg into a vein (IV)
• Natalizumab 600 mg IV or
• Placebo IV (looks like the genuine medication but contains no active ingredients)Participants have an equal chance of being placed in to these arms. Neither the participant nor the study doctor will know which arm the participant is in. The participant will be in this study for approximately 90 days with assessments 24 hours following dosing, 5 days, 30 days and 90 days after dosing.
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/0886
Date of REC Opinion
4 Aug 2016
REC opinion
Further Information Favourable Opinion