Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction (CHARM)
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| ClinicalTrials.gov Identifier: NCT02864953 |
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Recruitment Status :
Terminated
(Early completed to operational challenges and other strategic considerations, not for efficacy or safety reasons)
First Posted : August 12, 2016
Results First Posted : January 9, 2024
Last Update Posted : April 30, 2024
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Sponsor:
Remedy Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Remedy Pharmaceuticals, Inc.
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| Study Type | Interventional |
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| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Conditions |
Brain Edema Stroke, Acute |
| Interventions |
Drug: BIIB093 Drug: Placebo |
| Enrollment | 535 |
Participant Flow
| Recruitment Details | Participants were enrolled at investigative sites in the United States, Brazil, China, Spain, Japan, Australia, Portugal, Germany, United Kingdom, Finland, Canada, Israel, France, Taiwan, Hungary, Czech Republic, Italy, Belgium, Lithuania, Russia and South Korea from 29 August 2018 to 18 August 2023. |
| Pre-assignment Details | A total of 535 participants were enrolled and randomised, out of which 518 participants were dosed with BIIB093 or a matching placebo. |
| Arm/Group Title | Placebo | BIIB093 |
|---|---|---|
 Arm/Group Description |
Participants were administered with BIIB093 matching placebo as an intravenous (IV) bolus on Day 1 followed by a continuous IV infusion for over 72 hours. | Participants were administered with BIIB093 as an IV bolus on Day 1 followed by continuous IV infusion for over 72 hours. |
| Period Title: Overall Study | ||
| Started | 268 | 267 |
| Completed | 215 | 213 |
| Not Completed | 53 | 54 |
| Reason Not Completed | ||
| Adverse Event | 22 | 19 |
| Withdrawal by Subject | 1 | 0 |
| Physician Decision | 4 | 2 |
| Death | 3 | 13 |
| Reason not specified | 14 | 12 |
| Withdrew Prior to Dosing | 9 | 8 |
Baseline Characteristics
| Arm/Group Title | Placebo | BIIB093 | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants were administered with BIIB093 matching placebo as an IV bolus on Day 1 followed by a continuous IV infusion for over 72 hours. | Participants were administered with BIIB093 as an IV bolus on Day 1 followed by continuous IV infusion for over 72 hours. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 268 | 267 | 535 | |
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Baseline Analysis Population Description |
The Intent-to-treat (ITT) population included all randomized participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 268 participants | 267 participants | 535 participants | |
| 61.6 (10.81) | 60.5 (11.17) | 61.1 (11) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 268 participants | 267 participants | 535 participants | |
| Female |
104 38.8%
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98 36.7%
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202 37.8%
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| Male |
164 61.2%
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169 63.3%
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333 62.2%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Ethnicity | Number Analyzed | 268 participants | 267 participants | 535 participants |
| Missing |
1 0.4%
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2 0.7%
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3 0.6%
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| Hispanic or Latino |
36 13.4%
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41 15.4%
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77 14.4%
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| Not Hispanic or Latino |
228 85.1%
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223 83.5%
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451 84.3%
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| Not reported |
3 1.1%
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1 0.4%
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4 0.7%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Race | Number Analyzed | 268 participants | 267 participants | 535 participants |
| Missing |
3 1.1%
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2 0.7%
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5 0.9%
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| American Indian or Alaska Native |
1 0.4%
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1 0.4%
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2 0.4%
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| Asian |
53 19.8%
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51 19.1%
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104 19.4%
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| Black or African American |
21 7.8%
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19 7.1%
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40 7.5%
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| Native Hawaiian or Other Pacific Islander |
2 0.7%
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0 0.0%
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2 0.4%
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| White |
173 64.6%
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177 66.3%
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350 65.4%
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| Not reported due to confidentiality regulations |
3 1.1%
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1 0.4%
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4 0.7%
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| Other |
12 4.5%
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16 6.0%
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28 5.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
Early termination of trial due to operational challenges and other strategic considerations, not for efficacy or safety reasons.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
| Name/Title: | US Biogen Clinical Trial Center |
| Organization: | Biogen |
| Phone: | 866-633-4636 |
| EMail: | clinicaltrials@biogen.com |
| Responsible Party: | Remedy Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT02864953 |
| Obsolete Identifiers: | NCT04950972 |
| Other Study ID Numbers: |
252LH301 RPI 301 ( Other Identifier: Remedy Pharmaceuticals ) 2017-004854-41 ( EudraCT Number ) |
| First Submitted: | July 12, 2016 |
| First Posted: | August 12, 2016 |
| Results First Submitted: | December 19, 2023 |
| Results First Posted: | January 9, 2024 |
| Last Update Posted: | April 30, 2024 |