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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
Date last updated
25/11/2024

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
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
Secondary ID [1] 0 0
RPI 301
Secondary ID [2] 0 0
252LH301
Universal Trial Number (UTN)
Trial acronym
CHARM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Edema 0 0
Stroke, Acute 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Percentage of Participants With Improvement in Functional Outcome at Day 90 Assessed Via the Modified Rankin Scale (mRS)
Timepoint [1] 0 0
Day 90
Secondary outcome [1] 0 0
Part 1: Time to All-Cause Death Through Day 90
Timepoint [1] 0 0
Randomization up to Day 90
Secondary outcome [2] 0 0
Part 1: Percentage of Participants Who Achieved mRS 0-4 at Day 90
Timepoint [2] 0 0
Day 90
Secondary outcome [3] 0 0
Part 1: Midline Shift at 72 Hours as Assessed by Non-contrast Computed Tomography (NCCT) or Magnetic Resonance Imaging (MRI)
Timepoint [3] 0 0
At 72 hours
Secondary outcome [4] 0 0
Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [4] 0 0
From the signing of informed consent up to the last follow-up visit (up to 4 years 11 months)

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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/08/2023
Sample size
Target
Accrual to date
Final
535
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
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
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
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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3021 - St Albans
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Remedy Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02864953
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Remedy Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02864953