252LH301: Efficacy & Safety of IV BIIB093 (The CHARM Study)
Research type
Research Study
Full title
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction
IRAS ID
248467
Contact name
Nikola Sprigg
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2017-004854-41
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
128581, IND Number
Duration of Study in the UK
2 years, 9 months, 8 days
Research summary
This study is being conducted to determine if BIIB093 improves functional outcomes (the ability to do normal daily activities, such as walking and getting dressed) of participants who have had a type of stroke, called a large hemispheric infarction (LHI) when compared to placebo. This study will also look at the long-term effects of the study drug over time and see how safe it is. Previous studies showed that the study drug may reduce brain swelling, disability, and death in patients with LHI. Currently, there are no medications available to specifically reduce brain swelling caused by LHI.
Around 680 participants around the world will take part in this study. The number of participants in this study may increase to up to around 920.
Participation in the study will last approximately 12 months. The study will have a screening period, a treatment period (72 hours/3 days), and a follow-up period (52 weeks/1 year) and will be divided into two parts.
Part 1: The purpose of Part 1 is to look at how well the study drug works and how safe it is. It will last 3 months (Months 1–3). Participants will receive the study medication within 10 hours from the time they started having symptoms, or the time they were last seen to be well, as a continuous infusion over 72 hours. After being discharged from hospital, participants will have approximately 2 - 3 follow-up study visits.
Part 2: The purpose of Part 2 is to look at the long-term effects of the study drug on functional outcomes after a stroke. It will last 9 months (Months 4–12). Participants will have 2 visits completed by telephone at Months 6 and 12 and will complete questionnaires to check their ability to do normal daily activities over time.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
18/EM/0256
Date of REC Opinion
9 Nov 2018
REC opinion
Further Information Favourable Opinion