Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction
Public ClinicalTrials.gov record NCT02864953. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02864953
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 535 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 29, 2018 (Actual)
- Primary completion
- Aug 18, 2023 (Actual)
- Completion
- Aug 18, 2023 (Actual)
- Last update posted
- Nov 25, 2024
2018 – 2023
United States locations
- U.S. sites
- 74
- U.S. states
- 31
- U.S. cities
- 62
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | — |
| Arizona Board of Regents, University of Arizona | Tucson | Arizona | 85724 | — |
| Stanford Stroke Center | Palo Alto | California | 94304 | — |
| University of California Davis Health System | Sacramento | California | 95817 | — |
| UCSD Health-La Jolla | San Diego | California | 92121 | — |
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06519 | — |
| University of Florida-Gainsville | Gainesville | Florida | 32610 | — |
| Lyerly Neurosurgery Baptist Health | Jacksonville | Florida | 32207 | — |
| University of Florida, Jacksonville | Jacksonville | Florida | 32209 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| The Queens Medical Center | Honolulu | Hawaii | 96813 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | 66160 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham and Woman's Hospital | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center, Inc. | Jamaica Plain | Massachusetts | 02130-2075 | — |
| UMASS Memorial Medical Center | Worcester | Massachusetts | 01605 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| St. John's Hospital | Detroit | Michigan | 48236 | — |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Saint Louis University | St Louis | Missouri | 63110 | — |
| Washington University Physicians | St Louis | Missouri | 63110 | — |
| JFK Medical Center | Edison | New Jersey | 08820 | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | — |
| Rutgers - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | — |
| Valley Hospital | Ridgewood | New Jersey | 07450 | — |
| University of New Mexico | Albuquerque | New Mexico | 87106 | — |
| University of Buffalo | Buffalo | New York | 14215 | — |
| Northwell Health | Manhasset | New York | 11030 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| Columbia University Hervert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| SUNY Upstate Medical Center | Syracuse | New York | 13210 | — |
| UNC Hospitals | Chapel Hill | North Carolina | 27514 | — |
| Atrium Health Carolinas Medical Center | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Guilford Neurologic Research, PA | Greensboro | North Carolina | 27405 | — |
| Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | — |
| Wake Forest Baptist Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Summa Health System | Akron | Ohio | 44304 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State Univ College Of Medicine | Columbus | Ohio | 43210 | — |
| Miami Valley Hospital South | Dayton | Ohio | 45409 | — |
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 | — |
| Ascension St. John | Tulsa | Oklahoma | 74104 | — |
| Providence Brain and Spine Institute | Portland | Oregon | 97225 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | 18103 | — |
| Penn State University Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh School of Medicine | Pittsburgh | Pennsylvania | 15261 | — |
| Rhode Island Hospital Warren Alpert Medical School Brown University | Providence | Rhode Island | 02905 | — |
| Erlanger Health System | Chattanooga | Tennessee | 37403 | — |
| University of Tennessee Health Sciences Center | Memphis | Tennessee | 38163 | — |
| TriStar Skyline Medical Center | Nashville | Tennessee | 37207 | — |
| Vanderbilt Medical Center | Nashville | Tennessee | 37232 | — |
| St.David's HealthCare Office of Research | Austin | Texas | 78705 | — |
| Valley Baptist Medical Center | Harlingen | Texas | 78550 | — |
| University of Utah Neurology | Salt Lake City | Utah | 84108 | — |
| University of Washington School of Medicine | Seattle | Washington | 98195 | — |
| University Hospital and UW Health Clinics | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 176 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02864953, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 25, 2024 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02864953 live on ClinicalTrials.gov.