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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02864953
Registration number
NCT02864953
Ethics application status
Date submitted
12/07/2016
Date registered
12/08/2016
Titles & IDs
Public title
Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction
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Scientific 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
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Secondary ID [1]
0
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RPI 301
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Secondary ID [2]
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0
252LH301
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Universal Trial Number (UTN)
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Trial acronym
CHARM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Brain Edema
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0
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Stroke, Acute
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0
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Condition category
Condition code
Stroke
0
0
0
0
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Haemorrhagic
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Stroke
0
0
0
0
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Ischaemic
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Neurological
0
0
0
0
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Other neurological disorders
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Cardiovascular
0
0
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BIIB093
Treatment: Drugs - Placebo
Experimental: BIIB093 - BIIB093 administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
Placebo comparator: Placebo - Placebo administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
Treatment: Drugs: BIIB093
Administered as specified in the treatment arm.
Treatment: Drugs: Placebo
Administered as specified in the treatment arm.
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS)
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Assessment method [1]
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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.
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Timepoint [1]
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Day 90
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Secondary outcome [1]
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Part 1: Time to All-Cause Death Through Day 90
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Assessment method [1]
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Time to all-cause death is defined as the time from randomization to the time of death.
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Timepoint [1]
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Randomization up to Day 90
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Secondary outcome [2]
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Part 1: Percentage of Participants Who Achieved mRS 0-4 at Day 90
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Assessment method [2]
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0
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.
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Timepoint [2]
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Day 90
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Secondary outcome [3]
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Part 1: Midline Shift at 72 Hours as Assessed by Non-contrast Computed Tomography (NCCT) or Magnetic Resonance Imaging (MRI)
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Assessment method [3]
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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.
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Timepoint [3]
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At 72 hours
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Secondary outcome [4]
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Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [4]
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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.
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Timepoint [4]
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From the signing of informed consent up to the last follow-up visit (up to 4 years 11 months)
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Eligibility
Key inclusion criteria
1. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory.
2. A large hemispheric infarction defined as; lesion volume of 80 to 300 centimeters cubed (cm^3) on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP), or an Alberta Stroke Program Early CT Score (ASPECTS) of 1 to 5 with involvement of at least 2 defined cortical regions.
3. Screening National Institutes of Health Stroke Scale (NIHSS) >=10.
4. 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.
* Participants who wake with stroke may be included if neurological and other exclusion criteria are satisfied. The time of stroke onset is to be taken as the midpoint between sleep onset (or last known to be normal) and time of waking.
5. For participants who receive thrombectomy, inclusion into the study must be based on post-thrombectomy MRI-DWI.
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Participant is likely to have supportive care withdrawn on the first day.
2. Commitment to decompressive craniectomy (DC) prior to enrollment.
3. Evidence of concurrent infarction in the contralateral hemisphere sufficiently serious so as to affect functional outcome.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/08/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/08/2023
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Sample size
Target
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Accrual to date
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Final
535
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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John Hunter Hospital - New Lambton Heights
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Royal North Shore Hospital - St Leonards
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Princess Alexandra Hospital - Woolloongabba
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Royal Adelaide Hospital - Adelaide
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Monash Medical Centre - Clayton
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The Alfred Hospital - Melbourne
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Royal Melbourne Hospital - Parkville
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Sunshine Hospital - St Albans
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2170 - Liverpool
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2305 - New Lambton Heights
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2065 - St Leonards
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4102 - Woolloongabba
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5000 - Adelaide
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3168 - Clayton
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3004 - Melbourne
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3050 - Parkville
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Recruitment postcode(s) [9]
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3021 - St Albans
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Recruitment outside Australia
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Tel Aviv
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeongsangnam-do
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Korea, Republic of
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Busan
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Seoul
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Portugal
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Aveiro
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Portugal
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Porto
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Portugal
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Setubal
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Portugal
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Portugal
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Lisboa
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Russian Federation
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Leningrad
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Russian Federation
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Respublka Tatarstan
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Spain
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Barcelona
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Spain
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Spain
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La Coruña
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Málaga
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Girona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Valladolid
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Switzerland
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Ticino
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Switzerland
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Bern
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Taiwan
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Kaohsiung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
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Cambridgeshire
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United Kingdom
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Greater London
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United Kingdom
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Nottinghamshire
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United Kingdom
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Strathclyde
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United Kingdom
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Tyne & Wear
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Remedy Pharmaceuticals, Inc.
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02864953
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Contacts
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Medical Director
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Biogen
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/53/NCT02864953/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/53/NCT02864953/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02864953