A Phase 3 interventional study of BIIB093 and Placebo in Brain Edema and Stroke, Acute, sponsored by Remedy Pharmaceuticals, Inc.. Terminated at 250 sites in 24 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Remedy Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
The primary objective of Part 1 of the study 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 of Part 1 of the study 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.
The objectives of Part 2 of the study are 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.
102 studies on the registry are indexed under Brain Edema; 25 are open to participants now.
This study's enrollment of 535 is above the median of 60 across 62 interventional studies indexed under Brain Edema.
Browse Brain Edema studies →Remedy Pharmaceuticals, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At the time of randomization, and in the Investigator's judgement, it must be feasible for study drug treatment infusion to be initiated no later than 10 hours after time of symptom onset, if known, or the time last known normal.
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
BIIB093 administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
Drug: BIIB093
Placebo administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
Drug: Placebo
Administered as specified in the treatment arm.
Also known as: glibenclamide, glibenclamide intravenous (IV), glyburide, CIRARA
Administered as specified in the treatment arm.
Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS)
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.
Time frame: Day 90
Part 1: Time to All-Cause Death Through Day 90
Time to all-cause death is defined as the time from randomization to the time of death.
Time frame: Randomization up to Day 90
Part 1: Percentage of Participants Who Achieved mRS 0-4 at 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.
Time frame: Day 90
Part 1: Midline Shift at 72 Hours as Assessed by Non-contrast Computed Tomography (NCCT) or Magnetic Resonance Imaging (MRI)
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.
Time frame: At 72 hours
Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame: From the signing of informed consent up to the last follow-up visit (up to 4 years 11 months)
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.
| Milestone | Placebo | BIIB093 |
|---|---|---|
| Started | 268 | 267 |
| Completed | 215 | 213 |
| Not completed | 53 | 54 |
| Withdrew: Adverse event | 22 | 19 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Physician decision | 4 | 2 |
| Withdrew: Death | 3 | 13 |
| Withdrew: Reason not specified | 14 | 12 |
| Withdrew: Withdrew prior to dosing | 9 | 8 |
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.
| percentage of participants | Placebo | BIIB093 |
|---|---|---|
| Score: 0/1 | 1.4 | 3.2 |
| Score: 2 | 2.8 | 5.1 |
| Score: 3 | 12.6 | 12.0 |
| Score: 4 | 25.2 | 23.5 |
| Score: 5/6 | 57.9 | 56.2 |
Time to all-cause death is defined as the time from randomization to the time of death.
| days | Placebo | BIIB093 |
|---|---|---|
| Part 1: Time to All-Cause Death Through Day 90 | NA (37 to NA) | NA (18 to NA) |
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.
| percentage of participants | Placebo | BIIB093 |
|---|---|---|
| Part 1: Percentage of Participants Who Achieved mRS 0-4 at Day 90 | 41.6 | 42.9 |
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.
| millimeters (mm) | Placebo | BIIB093 |
|---|---|---|
| Part 1: Midline Shift at 72 Hours as Assessed by Non-contrast Computed Tomography (NCCT) or Magnetic Resonance Imaging (MRI) | 6.32 ± 4.760 | 7.02 ± 4.565 |
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.
| percentage of participants | Placebo | BIIB093 |
|---|---|---|
| AEs | 95.4 | 97.3 |
| SAEs | 68.3 | 76.8 |
Collected over From the signing of informed consent up to the last follow-up visit (up to 4 years 11 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 97/259 (37.5%) | 177/259 (68.3%) | 199/259 (76.8%) |
| BIIB093 | 103/259 (39.8%) | 199/259 (76.8%) | 201/259 (77.6%) |
| Event | Placebo | BIIB093 |
|---|---|---|
| Brain oedemaNervous system disorders | 79/259 | 72/259 |
| Brain herniationInjury, poisoning and procedural complications | 16/259 | 19/259 |
| PneumoniaInfections and infestations | 18/259 | 13/259 |
| Cerebrovascular accidentNervous system disorders | 5/259 | 17/259 |
| Haemorrhagic transformation strokeNervous system disorders | 16/259 | 14/259 |
| HypoglycaemiaMetabolism and nutrition disorders | 4/259 | 15/259 |
| Stroke in evolutionNervous system disorders | 6/259 | 14/259 |
| Neurological procedural complicationInjury, poisoning and procedural complications | 12/259 | 11/259 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 11/259 | 10/259 |
| Cerebral infarctionNervous system disorders | 8/259 | 10/259 |
| Event | Placebo | BIIB093 |
|---|---|---|
| PyrexiaGeneral disorders | 57/259 | 66/259 |
| ConstipationGastrointestinal disorders | 54/259 | 40/259 |
| Urinary tract infectionInfections and infestations | 41/259 | 29/259 |
| PneumoniaInfections and infestations | 40/259 | 32/259 |
| HypokalaemiaMetabolism and nutrition disorders | 32/259 | 35/259 |
| HypoglycaemiaMetabolism and nutrition disorders | 8/259 | 31/259 |
| AnaemiaBlood and lymphatic system disorders | 28/259 | 25/259 |
| Brain oedemaNervous system disorders | 28/259 | 28/259 |
| HeadacheNervous system disorders | 27/259 | 22/259 |
| VomitingGastrointestinal disorders | 26/259 | 22/259 |
The Intent-to-treat (ITT) population included all randomized participants.
| Age, Continuous(years) | Placebo | BIIB093 | Total |
|---|---|---|---|
| Mean | 61.6 ± 10.81 | 60.5 ± 11.17 | 61.1 ± 11 |
| Sex: Female, Male(Participants) | Placebo | BIIB093 | Total |
|---|---|---|---|
| Female | 104 | 98 | 202 |
| Male | 164 | 169 | 333 |
| Race/Ethnicity, Customized(Participants) | Placebo | BIIB093 | Total |
|---|---|---|---|
| Ethnicity — Missing | 1 | 2 | 3 |
| Ethnicity — Hispanic or Latino | 36 | 41 | 77 |
| Ethnicity — Not Hispanic or Latino | 228 | 223 | 451 |
| Ethnicity — Not reported | 3 | 1 | 4 |
| Race/Ethnicity, Customized(Participants) | Placebo | BIIB093 | Total |
|---|---|---|---|
| Race — Missing | 3 | 2 | 5 |
| Race — American Indian or Alaska Native | 1 | 1 | 2 |
| Race — Asian | 53 | 51 | 104 |
| Race — Black or African American | 21 | 19 | 40 |
| Race — Native Hawaiian or Other Pacific Islander | 2 | 0 | 2 |
| Race — White | 173 | 177 | 350 |
| Race — Not reported due to confidentiality regulations | 3 | 1 | 4 |
| Race — Other | 12 | 16 | 28 |
Showing the first 100 of 250 sites across 24 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Glyburide
Remedy Pharmaceuticals, Inc.