Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02864953
Previous Study | Return to List | Next Study

Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction (CHARM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02864953
Recruitment Status : Recruiting
First Posted : August 12, 2016
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE July 12, 2016
First Posted Date  ICMJE August 12, 2016
Last Update Posted Date February 18, 2020
Actual Study Start Date  ICMJE August 29, 2018
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
Proportion of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS) [ Time Frame: Baseline up to Day 90 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2016)
Proportion of participants with improvement in functional outcome at 90 days assessed via the modified Rankin Scale [ Time Frame: Change from baseline at 90 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
  • Time to All-Cause Death [ Time Frame: Baseline up to Day 90 ]
  • Proportion of Participants Who Achieved mRS 0-4 at Day 90 [ Time Frame: Baseline up to Day 90 ]
  • Reduction in Midline Shift at 72 Hours [ Time Frame: Baseline up to 72 hours ]
  • Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 90 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2016)
  • Proportion of participants with improvement in overall survival at 90 days [ Time Frame: Change from baseline at 90 days ]
  • Proportion of participants with a reduction in midline shift at 72 hours assessed via non-contrast computed tomography [ Time Frame: Change from baseline at 72 hours ]
  • Safety of CIRARA via collection of adverse events and serious adverse events [ Time Frame: Change from baseline through 15 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction
Official Title  ICMJE 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
Brief Summary The primary objective is to determine if BIIB093 improves functional outcome at Day 90 as measured by the modified Rankin Scale (mRS) when compared with placebo in participants with Large Hemispheric Infarction (LHI). The secondary objectives are to determine if BIIB093 improves overall survival at Day 90 when compared with placebo, if BIIB093 improves functional outcome at Day 90 on the mRS dichotomized 0-4 vs. 5-6 when compared with placebo, if BIIB093 reduces midline shift at 72 hours (or at time of decompressive craniectomy [DC] or comfort measures only [CMO], if earlier) when compared with placebo, and to evaluate the safety and tolerability of BIIB093 in participants with LHI.
Detailed Description This study, previously posted by Remedy Pharmaceuticals, Inc., has transitioned to Biogen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Edema
  • Stroke, Acute
Intervention  ICMJE
  • Drug: BIIB093
    Administered as specified in the treatment arm.
    Other Names:
    • glibenclamide
    • glibenclamide intravenous (IV)
    • glyburide
    • CIRARA
  • Drug: Placebo
    Administered as specified in the treatment arm.
Study Arms  ICMJE
  • Experimental: BIIB093
    BIIB093 administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
    Intervention: Drug: BIIB093
  • Placebo Comparator: Placebo
    Placebo administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2018)
680
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2016)
650
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory
  2. A large hemispheric infarction defined as; lesion volume of 80 to 300 centimeters cubed (cm^3) on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP), or an Alberta Stroke Program Early CT Score (ASPECTS) of 1 to 5 with involvement of at least 2 defined cortical regions
  3. Screening National Institutes of Health Stroke Scale (NIHSS) >=10
  4. Study treatment infusion within 10 hours after time of symptom onset, if known, or the time last known normal
  5. For participants who receive thrombectomy, inclusion into the study must be based on post-thrombectomy MRI-DWI

Exclusion Criteria:

  1. Participant is likely to have supportive care withdrawn on the first day
  2. Commitment to decompressive craniectomy (DC) prior to enrollment
  3. Evidence of concurrent infarction in the contralateral hemisphere sufficiently serious so as to affect functional outcome

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   China,   Croatia,   Czechia,   Denmark,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Lithuania,   Portugal,   Russian Federation,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02864953
Other Study ID Numbers  ICMJE 252LH301
RPI 301 ( Other Identifier: Remedy Pharmaceuticals )
2017-004854-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP