Trial · NCT02864953
Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction
NCT02864953, Phase 3, Terminated, Remedy Pharmaceuticals, Inc.; results first posted 2024-01-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction. Trials, record NCT02864953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02864953
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction
- NCT number
- NCT02864953
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 535 participants, actual
- Lead sponsor
- Remedy Pharmaceuticals, Inc.
- Conditions
- Brain Edema, Stroke, Acute
- Interventions
- BIIB093, Placebo
- First posted
- 2016-08-12
- Last updated
- 2024-11-25
- Other registries' IDs
- eudract:2017-004854-41
- Results first posted
- 2024-01-09
- Limitations and caveats
- Early termination of trial due to operational challenges and other strategic considerations, not for efficacy or safety reasons.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS) | Day 90 | The mRS measures the degree of functional independence following stroke. In this study, 7-category ordinal mRS scale was condensed to the following 5-categories: 0/1, 2, 3, 4, 5/6 where 0 and 1 reflect no disability and near-normal functioning while 5 and 6 represent severe disability and death, respectively. |
| Secondary | Part 1: Time to All-Cause Death Through Day 90 | Randomization up to Day 90 | Time to all-cause death is defined as the time from randomization to the time of death. |
| Secondary | Part 1: Percentage of Participants Who Achieved mRS 0-4 at Day 90 | Day 90 | The mRS measures the degree of functional independence following stroke. In this study, the 7-category ordinal mRS scale was condensed to the following 5-categories: 0/1, 2, 3, 4, 5/6 where 0 and 1 reflect no disability and near-normal functioning while 5 and 6 represent severe disability and death, respectively. |
| Secondary | Part 1: Midline Shift at 72 Hours as Assessed by Non-contrast Computed Tomography (NCCT) or Magnetic Resonance Imaging (MRI) | At 72 hours | Midline shift is the perpendicular distance between the septum pellucidum and the line drawn between the anterior and posterior attachments of the falx to the inner table of the skull. |
| Secondary | Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the signing of informed consent up to the last follow-up visit (up to 4 years 11 months) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS) | Day 90 | The modified intent to treat (mITT) population included participants aged 18 to 70 years (inclusive) at the time of randomization, who had received any study drug, and who had at least 1 post-baseline mRS before or at Day 90 visit. Here, 'Overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. | percentage of participants | NUMBER |
| SECONDARY | Part 1: Time to All-Cause Death Through Day 90 | Randomization up to Day 90 | The mITT population included participants aged 18 to 70 years (inclusive) at the time of randomization, who received any study drug, and who had at least 1 post-baseline mRS before or at the Day 90 visit. Here, 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. | days | MEDIAN |
| SECONDARY | Part 1: Percentage of Participants Who Achieved mRS 0-4 at Day 90 | Day 90 | The mITT population included participants aged 18 to 70 years (inclusive) at the time of randomization, who received any study drug, and who had at least 1 post-baseline mRS before or at the Day 90 visit. Here, 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. | percentage of participants | NUMBER |
| SECONDARY | Part 1: Midline Shift at 72 Hours as Assessed by Non-contrast Computed Tomography (NCCT) or Magnetic Resonance Imaging (MRI) | At 72 hours | The mITT population included participants aged 18 to 70 years (inclusive) at the time of randomization, who received any study drug, and who had at least 1 post-baseline mRS before or at the Day 90 visit. Here, 'Overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. | millimeters (mm) | MEAN |
| SECONDARY | Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the signing of informed consent up to the last follow-up visit (up to 4 years 11 months) | The safety population included all participants who were enrolled and had received any portion of the infusion of study treatment (placebo or BIIB093). Here, 'Overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS) | Placebo | Score: 0/1 | 1.4 | percentage of participants | |
| Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS) | BIIB093 | Score: 0/1 | 3.2 | percentage of participants | |
| Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS) | Placebo | Score: 2 | 2.8 | percentage of participants | |
| Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS) | BIIB093 | Score: 2 | 5.1 | percentage of participants | |
| Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS) | Placebo | Score: 3 | 12.6 | percentage of participants | |
| Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS) | BIIB093 | Score: 3 | 12.0 | percentage of participants | |
| Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS) | Placebo | Score: 4 | 25.2 | percentage of participants | |
| Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS) | BIIB093 | Score: 4 | 23.5 | percentage of participants | |
| Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS) | Placebo | Score: 5/6 | 57.9 | percentage of participants | |
| Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS) | BIIB093 | Score: 5/6 | 56.2 | percentage of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 268 | |
| Overall Study | STARTED | BIIB093 | 267 | |
| Overall Study | COMPLETED | Placebo | 215 | |
| Overall Study | COMPLETED | BIIB093 | 213 | |
| Overall Study | NOT COMPLETED | Placebo | 53 | |
| Overall Study | NOT COMPLETED | BIIB093 | 54 |
Source ClinicalTrials.gov
Adverse events456
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 28 | 259 | |
| other | Anaemia | Blood and lymphatic system disorders | BIIB093 | 25 | 259 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 21 | 259 | |
| other | Leukocytosis | Blood and lymphatic system disorders | BIIB093 | 16 | 259 | |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 22 | 259 | |
| other | Atrial fibrillation | Cardiac disorders | BIIB093 | 17 | 259 | |
| other | Bradycardia | Cardiac disorders | Placebo | 13 | 259 | |
| other | Bradycardia | Cardiac disorders | BIIB093 | 13 | 259 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 54 | 259 | |
| other | Constipation | Gastrointestinal disorders | BIIB093 | 40 | 259 |
1 to 10 of 456Source ClinicalTrials.gov
See all 456 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 97 | 259 |
| Total, all-cause mortality | BIIB093 | 103 | 259 |
| Total, other adverse events | Placebo | 199 | 259 |
| Total, other adverse events | BIIB093 | 201 | 259 |
| Total, serious adverse events | Placebo | 177 | 259 |
| Total, serious adverse events | BIIB093 | 199 | 259 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BIIB093 vs Placebo: deaths from any cause | Trial comparisons |
| BIIB093 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02864953
GET https://conductscience.org/api/trials/v1/NCT02864953/events?page=2