CHARM: Glibenclamide for Large Hemispheric Infarction Analyzing mRS and Mortality. A Multicenter Double-Blind Placebo-Controlled Randomized Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Severe Cerebral Ed | NYU Langone Health

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CHARM: Glibenclamide for Large Hemispheric Infarction Analyzing mRS and Mortality. A Multicenter Double-Blind Placebo-Controlled Randomized Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Severe Cerebral Ed

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Large Hemispheric Infarction (lhi); Stroke
Age: Between 18 years - 85 years
Gender: Male or Female

Other Inclusion Criteria:
1. Male and female subjects who are between the ages of 18 and 85
2. Subjects with a clinical diagnosis of acute ischemic stroke in the MCA territory
3. Subjects with a large hemispheric infarction defined as per the protocol
4. Subjects who are able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information
5. Subjects who receive thrombectomy prior to randomization, inclusion into the study must be based on an infarct volume of 80 to 300 cm3 measured by post-thrombectomy MRI-DWI.
6. Subjects who are able to start Study drug treatment infusion as soon as possible but no later than 10 hours after time of symptom onset

You may not be eligible for this study if the following are true:

1. Subjects is likely to have supportive care withdrawn in the first day, in the judgment of the Investigator
2. Subjects who have commitment to decompressive craniectomy (DC) prior to enrollment
3. Subjects who have evidence (clinical or imaging) of concurrent infarction in the contralateral hemisphere deemed by the Investigator to be sufficiently serious so as to affect functional outcome
4. Subjects who have impaired cognitive capabilities or unable to provide written informed consent
5. Subjects with clinical signs of herniation, brain hemorrhage, and has evidence of anteroseptal/pineal shift >2 mm
6. Subjects who use intra-arterial thrombolytic agents, alone or in combination with thrombectomy
7. Subjects who are currently being considered for thrombectomy and/or IV thrombolysis may not be randomized into the study until these procedures have been completed OR the decision not to perform them has been made
8. Subjects with a life expectancy of less than 3 months
9. Subjects whose peripheral IV line cannot be placed
10. Subjects with mental disability or are wards of the state
11. Subjects with stroke symptoms are rapidly improving and are not expected in the opinion of the Investigator to have NIHSS≥10 at the time of randomization.