ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Not yet recruiting
First Posted : August 12, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
This study evaluates the use of the investigational drug BIIB093 versus placebo in patients with a large hemispheric infarction.

Condition or disease Intervention/treatment Phase
Brain Edema Stroke, Acute Drug: BIIB093 Drug: Placebo Phase 3

Detailed Description:
This study, previously posted by Remedy Pharmaceuticals, Inc., has transitioned to Biogen with the acquisition of CIRARA.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : June 29, 2018
Estimated Primary Completion Date : September 28, 2020
Estimated Study Completion Date : June 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Glyburide

Arm Intervention/treatment
Experimental: BIIB093
BIIB093 administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
Drug: BIIB093
Administered as specified in the treatment arm.
Other Names:
  • glibenclamide
  • glibenclamide intravenous (IV)
  • glyburide
  • CIRARA

Placebo Comparator: Placebo
Placebo administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
Drug: Placebo
Administered as specified in the treatment arm.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Time to All-Cause Death [ Time Frame: Baseline up to Day 90 ]
  2. Proportion of Participants Who Achieved mRS 0-4 at Day 90 [ Time Frame: Baseline up to Day 90 ]
  3. Reduction in Midline Shift at 72 Hours [ Time Frame: Baseline up to 72 hours ]
  4. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 90 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864953


Contacts
Contact: US Biogen Medical Information 866-633-4636 clinicaltrials@biogen.com

Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02864953     History of Changes
Other Study ID Numbers: 252LH301
RPI 301 ( Other Identifier: Remedy Pharmaceuticals )
2017-004854-41 ( EudraCT Number )
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biogen:
Stroke
Infarction
Cerebrovascular Disorders
Brain Diseases
Brain Edema Ischemia
Pathological Processes Necrosis
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs

Additional relevant MeSH terms:
Infarction
Edema
Stroke
Brain Edema
Ischemia
Pathologic Processes
Necrosis
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs