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Sulfonylurea

BIIB093 for Brain Swelling (CHARM Trial)

Phase 3
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6 and 12
Awards & highlights

CHARM Trial Summary

This trial is testing whether a drug called BIIB093 improves functional outcome for people with Large Hemispheric Infarction (LHI) compared to placebo. The trial has two parts. The first part is to determine if the drug improves functional outcome at Day 90 and overall survival at Day 90. The second part is to evaluate long-term disability following LHI, to evaluate long-term outcome measures of clinical function, quality of life, and healthcare utilization, and to assess the safety of BIIB093 in subjects with LHI during the follow-up period.

Eligible Conditions
  • Brain Swelling
  • Stroke

CHARM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS)
Secondary outcome measures
Part 1: Midline Shift at 72 Hours as Assessed by Non-contrast Computed Tomography (NCCT) or Magnetic Resonance Imaging (MRI)
Part 1: Percentage of Participants Who Achieved mRS 0-4 at Day 90
Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
+1 more
Other outcome measures
Part 2: Barthel Index (BI) Score
Part 2: EuroQol 5-Level Assessment of Health Outcomes (EQ-5D-5L) Score
Part 2: HealthCare Resource Utilization (HCRU) Questionnaire: Number of Participants With Visits to Healthcare Professionals for Treatment
+4 more

CHARM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BIIB093Experimental Treatment1 Intervention
BIIB093 administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
466,901 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,062,945 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I join this clinical trial, given my medical history?

"This brain swelling study is recruiting up to 768 individuals that are between 18-85 years old."

Answered by AI

What are the chances that a patient will experience negative side effects from BIIB093?

"BIIB093 is in Phase 3 of clinical trials, so it has received a score of 3 for safety. This is due to the presence of data supporting efficacy as well as multiple rounds of data that confirm its safety."

Answered by AI

Are the participating hospitals located only in Canada?

"This study, which is still recruiting patients, has 63 total enrolment sites. Some of these are in New york and Hershey while others are located in Providence or other areas. If you decide to participate in this trial, try to choose a clinic that is close to reduce travel time and effort."

Answered by AI

What is the efficacy of BIIB093 in other medical investigations?

"There are currently 7 different studies being conducted for BIIB093, 2 of which are in the third and final stage. The many trials for BIIB093 have their origins in Beijing but can be found in 306 locations total."

Answered by AI

Could you tell me if the elderly are able to participate in this research?

"In order to meet the requirements for this clinical trial, applicants must fall between 18 and 85 years of age. Out of the 62 similar studies, 1464 are available for people that exceed the age limit by 65+."

Answered by AI

Are investigators still looking for more test subjects?

"That is correct, the online clinicaltrials.gov registry shows that this study is still recruiting patients. This trial was posted on August 29th, 2018 and last updated April 18th, 2022. There are currently 63 sites enrolling a total of 768 participants."

Answered by AI

Who else is applying?

What state do they live in?
New York
Georgia
How old are they?
65+
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction
2018. "Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02864953.
~81 spots leftby Apr 2025
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