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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003858-24 | EudraCT Number |
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Early completed due to strategic considerations, not for efficacy or safety reasons.
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The primary objective is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo.
The secondary objectives are to evaluate the effects of BIIB093 on acute neurologic status, functional outcomes, and treatment requirements, to further differentiate the mechanism of action of BIIB093 on contusion expansion by examining differential effects on hematoma and edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB093 3 mg | Experimental | Participants will be administered BIIB093 3 milligrams per day (mg/day) as a IV bolus followed by rapid and slow intravenous (IV) infusions for 96 hours. |
|
| BIIB093 5 mg | Experimental | Participants will be administered BIIB093 5 mg/day as a IV bolus followed by rapid and slow IV infusions for 96 hours. |
|
| Placebo | Placebo Comparator | Participants will be administered BIIB093 matching placebo as a IV bolus followed by rapid and slow IV infusions for 96 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB093 | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging | Total contusion volume including hematoma and perihematomal edema volumes reported in milliliters (mL) was assessed by the central imaging core laboratory on baseline non-contrast computed tomography (NCCT), 24-hour NCCT, and the 96-hour scan (Magnetic resonance imaging [MRI] and/or NCCT) and the scans obtained prior to decompressive craniectomy (DC), intraparenchymal hematoma (IPH) evacuation, or comfort measures only (CMO). | Baseline up to 96 hours (Day 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | The GOS-E is a global disability scale used to assess recovery after traumatic brain injury. For this study, the 8 point ordinal scale was condensed to the following 7-categories: 1 and 2 combined: Dead and Vegetative State, 3: Lower Severe disability, 4: Upper Severe disability, 5: Lower Moderate disability, 6: Upper Moderate disability, 7 : Lower Good recovery, and 8: Upper Good Recovery. Lower scores indicate death and higher scores indicate recovery. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Remedy Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| Scottsdale Healthcare Hospitals d/b/a HonorHealth |
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A total of 92 participants were enrolled and randomized, out of which 86 participants were dosed with BIIB093 or a matching placebo.
Participants were enrolled at study centers in Israel, France, Japan, Italy, Spain, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants were administered with BIIB093 matching placebo as an intravenous (IV) bolus followed by a rapid IV infusion and a slow IV infusion for 4 days. |
| FG001 | BIIB093 3 mg/Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 14, 2022 | Nov 29, 2023 |
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| Placebo | Drug | Administered as specified in the treatment arm. |
|
| Day 180 |
| Percentage of Participants With Modified Rankin Scale (mRS) Score 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. | Day 90 |
| Percentage of Participants Requiring Delayed Intubation | Delayed intubation is defined as participants requiring intubation (for neurologic deterioration only) at any time between 24 hours and 96 hours post-injury. | Day 1 (24 hours) up to Day 4 (96 hours) post-injury |
| Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging | Total contusion volume including hematoma and perihematomal edema volumes reported in mL was assessed by the central imaging core laboratory on baseline NCCT and 24-hour NCCT. | Baseline up to 24 hours (Day 1) |
| Change From Baseline in Absolute Hematoma Volume at 24 Hours | Hematoma volume reported in mL was assessed by the central imaging core laboratory on baseline NCCT, 24-hour NCCT, and the scans obtained prior to DC, IPH evacuation, or CMO. | Baseline up to 24 hours (Day 1) |
| Change From Baseline in Absolute Edema Volume at 96 Hours | Edema volume reported in mL was assessed by the central imaging core laboratory on baseline NCCT, 24-hour NCCT, and the 96-hour scan (MRI and/or NCCT) and the scans obtained prior to DC, IPH evacuation, or CMO. | Baseline up to 96 hours (Day 4) |
| 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 and includes all-cause death along with neurological death. | Randomization up to Day 90 |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| University of Arizona Medical Center | Tucson | Arizona | 85724 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| WellStar Medical Group Neurosurgery | Marietta | Georgia | 30060 | United States |
| Goodman Campbell Brain and Spine | Carmel | Indiana | 46032 | United States |
| University Medical Center New Orleans | New Orleans | Louisiana | 70119 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Northwell Health | Manhattan | New York | 11030 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| Vidant Medical Center | Greenville | North Carolina | 27834 | United States |
| Wake Forest Baptist Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati College of Medicine | Cincinnati | Ohio | 45219 | United States |
| Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Rhode Island Hospital | East Providence | Rhode Island | 02915-2237 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| University of Utah Health | Salt Lake City | Utah | 84132 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298-0599 | United States |
| CHU de Brest - Hôpital de la Cavale Blanche | Brest | Finistere | 29200 | France |
| Hopital Caremeau | Nîmes | Gard | 30029 | France |
| Groupe Hospitalier Pellegrin - Hôpital Pellegrin | Bordeaux | Gironde | 33076 | France |
| CHU Rennes - Hôpital Pontchaillou | Rennes | Ille Et Vilaine | 35033 | France |
| CHU Clermont Ferrand - Hopital Gabriel Montpied | Clermont-Ferrand | Puy De Dome | 63003 | France |
| CHU Amiens - Hopital Sud | Amiens | Somme | 80054 | France |
| Universitaetsklinikum Heidelberg | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Neurologische Klinik Bad Neustadt/Saale | Bad Neustadt/Saale | Bavaria | 97616 | Germany |
| Universitaetsmedizin Goettingen | Göttingen | Lower Saxony | 37075 | Germany |
| Universitaetsklinikum Schleswig-Holstein - Campus Kiel | Kiel | Schleswig | 24105 | Germany |
| Rabin MC | Petah Tikva | Central District | 49100 | Israel |
| Health Corporation of Galilee Medical Center | Naharya | Northern District | 22100 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Rambam Health Care Center | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Hadassah | Jerusalem | 9112001 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona | Torrette | Ancona | 60020 | Italy |
| ASST Monza - Ospedale San Gerardo di Monza | Monza Brianza | Milano | 20900 | Italy |
| Azienda Ospedaliero Universitaria di Parma | Pama | Parma | 43126 | Italy |
| Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) | Milan | 20162 | Italy |
| Ospedale Maggiore di Novara | Novara | 28100 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | 00137 | Italy |
| Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino | Torino | 10126 | Italy |
| Kimitsu Chuo Hospital | Kisarazu-Shi | Chiba | 292-8535 | Japan |
| Kobe City Hospital Organization Kobe City Medical Center General Hospital | Kobe | Hyōgo | 650-0047 | Japan |
| Nara Medical University Hospital | Kashihara-shi | Nara | 634-8522 | Japan |
| Rinku General Medical Center | Izumisano | Osaka | 598-8577 | Japan |
| Nippon Medical School Hospital | Bunkyō City | Tokyo-to | 113-8603 | Japan |
| Yamaguchi University Hospital | Ube-Shi | Yamaguchi | 755-8505 | Japan |
| Hospital Universitari Son Espases | Palma de Mallorca | Balearic Islands | 07120 | Spain |
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | La Coruna | 15706 | Spain |
| Hospital Alvaro Cunqueiro | Vigo | Pontevedra | 36312 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitari de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
Participants were administered with BIIB093 up to 3 milligrams per day (mg/day) as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
| FG002 | BIIB093 5 mg/Day | Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All dosed population included all the randomized participants who received any study drug (BIIB093 or a placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants were administered with BIIB093 matching placebo as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days. |
| BG001 | BIIB093 3 mg/Day | Participants were administered with BIIB093 up to 3 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days. |
| BG002 | BIIB093 5 mg/Day | Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging | Total contusion volume including hematoma and perihematomal edema volumes reported in milliliters (mL) was assessed by the central imaging core laboratory on baseline non-contrast computed tomography (NCCT), 24-hour NCCT, and the 96-hour scan (Magnetic resonance imaging [MRI] and/or NCCT) and the scans obtained prior to decompressive craniectomy (DC), intraparenchymal hematoma (IPH) evacuation, or comfort measures only (CMO). | mITT population=all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | mL | Baseline up to 96 hours (Day 4) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | The GOS-E is a global disability scale used to assess recovery after traumatic brain injury. For this study, the 8 point ordinal scale was condensed to the following 7-categories: 1 and 2 combined: Dead and Vegetative State, 3: Lower Severe disability, 4: Upper Severe disability, 5: Lower Moderate disability, 6: Upper Moderate disability, 7 : Lower Good recovery, and 8: Upper Good Recovery. Lower scores indicate death and higher scores indicate recovery. | mITT population included all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. | Posted | Number | Percentage of participants | Day 180 |
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| Secondary | Percentage of Participants With Modified Rankin Scale (mRS) Score 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. | mITT population included all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit or NSx or CMO, if earlier. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. | Posted | Number | Percentage of participants | Day 90 |
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| Secondary | Percentage of Participants Requiring Delayed Intubation | Delayed intubation is defined as participants requiring intubation (for neurologic deterioration only) at any time between 24 hours and 96 hours post-injury. | mITT population included all the randomized participants who received any study drug (BIIB093 or placebo) and had at least one final read per central review of contusion volume from a NCCT or MRI scan acquired between 10 hours after the initiation of study drug infusion and the Hour 96 visit or NSx or CMO, if earlier. | Posted | Number | Percentage of participants | Day 1 (24 hours) up to Day 4 (96 hours) post-injury |
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| Secondary | Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging | Total contusion volume including hematoma and perihematomal edema volumes reported in mL was assessed by the central imaging core laboratory on baseline NCCT and 24-hour NCCT. | mITT population=all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | mL | Baseline up to 24 hours (Day 1) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Absolute Hematoma Volume at 24 Hours | Hematoma volume reported in mL was assessed by the central imaging core laboratory on baseline NCCT, 24-hour NCCT, and the scans obtained prior to DC, IPH evacuation, or CMO. | mITT population=all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | mL | Baseline up to 24 hours (Day 1) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Absolute Edema Volume at 96 Hours | Edema volume reported in mL was assessed by the central imaging core laboratory on baseline NCCT, 24-hour NCCT, and the 96-hour scan (MRI and/or NCCT) and the scans obtained prior to DC, IPH evacuation, or CMO. | mITT population=all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | mL | Baseline up to 96 hours (Day 4) |
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| Secondary | 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 and includes all-cause death along with neurological death. | mITT population included all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT or MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit or NSx or CMO, if earlier. 'Overall number of participants analyzed' signifies the number of participants who died from randomization up to Day 90. | Posted | Median | Inter-Quartile Range | days | Randomization up to Day 90 |
|
From signing of informed consent up to last follow-up visit (approximately 1360 days)
Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants were administered with BIIB093 matching placebo as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days. | 4 | 44 | 12 | 44 | 36 | 44 |
| EG001 | BIIB093 3mg/Day | Participants were administered with BIIB093 up to 3 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days. | 0 | 23 | 7 | 23 | 20 | 23 |
| EG002 | BIIB093 5mg/Day | Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days. | 2 | 19 | 8 | 19 | 18 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Korsakoff's syndrome | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dilutional anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anisocoria | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Proctitis haemorrhagic | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Medical device site erosion | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic cytolysis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Diverticulitis intestinal haemorrhagic | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Electroencephalogram abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Fibrin d dimer increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperchloraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anosmia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dementia with lewy bodies | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lateral medullary syndrome | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Subdural hygroma | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Priapism | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory alkalosis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
Early termination of trial due to strategic considerations, not for efficacy or safety reasons.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| US Biogen Clinical Trial Center | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 17, 2023 | Nov 29, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000070624 | Brain Contusion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D003288 | Contusions |
| D014949 | Wounds, Nonpenetrating |
Not provided
Not provided
| ID | Term |
|---|---|
| D005905 | Glyburide |
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Not Reported |
|
| Other |
|
| Change From Baseline at 96 Hours |
|
|
| BIIB093 5 mg/Day |
Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days. |
|
|
|
Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
|
|
|
|
|
Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
|
|
|
|
|
|
Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
|
|
|
|
|