Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
30/04/2024

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
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [9] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maine
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New Mexico
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Oregon
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
Rhode Island
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
United States of America
State/province [31] 0 0
Wisconsin
Country [32] 0 0
Belgium
State/province [32] 0 0
East Flanders
Country [33] 0 0
Belgium
State/province [33] 0 0
Flemish Brabant
Country [34] 0 0
Belgium
State/province [34] 0 0
Namur
Country [35] 0 0
Belgium
State/province [35] 0 0
Liege
Country [36] 0 0
Brazil
State/province [36] 0 0
Ceará
Country [37] 0 0
Brazil
State/province [37] 0 0
Paraná
Country [38] 0 0
Brazil
State/province [38] 0 0
Rio Grande Do Sul
Country [39] 0 0
Brazil
State/province [39] 0 0
Santa Catarina
Country [40] 0 0
Brazil
State/province [40] 0 0
Sao Paulo
Country [41] 0 0
Canada
State/province [41] 0 0
Alberta
Country [42] 0 0
China
State/province [42] 0 0
Anhui
Country [43] 0 0
China
State/province [43] 0 0
Beijing
Country [44] 0 0
China
State/province [44] 0 0
Bejing
Country [45] 0 0
China
State/province [45] 0 0
Guangdong
Country [46] 0 0
China
State/province [46] 0 0
Hainan
Country [47] 0 0
China
State/province [47] 0 0
Hubei
Country [48] 0 0
China
State/province [48] 0 0
Jiangsushe
Country [49] 0 0
China
State/province [49] 0 0
Jiangsu
Country [50] 0 0
China
State/province [50] 0 0
Jiangxi
Country [51] 0 0
China
State/province [51] 0 0
Jilin
Country [52] 0 0
China
State/province [52] 0 0
Shanghai
Country [53] 0 0
China
State/province [53] 0 0
Shanxi
Country [54] 0 0
China
State/province [54] 0 0
Sichuan
Country [55] 0 0
China
State/province [55] 0 0
Tianjin
Country [56] 0 0
China
State/province [56] 0 0
Zhejiang
Country [57] 0 0
Croatia
State/province [57] 0 0
Croatia Proper
Country [58] 0 0
Czechia
State/province [58] 0 0
Moravian-Silesian
Country [59] 0 0
Czechia
State/province [59] 0 0
Moravia
Country [60] 0 0
Czechia
State/province [60] 0 0
Prague
Country [61] 0 0
Czechia
State/province [61] 0 0
Hradec Kralove
Country [62] 0 0
Denmark
State/province [62] 0 0
Copenhagen City
Country [63] 0 0
Denmark
State/province [63] 0 0
Østsjælland
Country [64] 0 0
Finland
State/province [64] 0 0
Southern
Country [65] 0 0
Finland
State/province [65] 0 0
Western
Country [66] 0 0
France
State/province [66] 0 0
Calvados
Country [67] 0 0
France
State/province [67] 0 0
Doubs
Country [68] 0 0
France
State/province [68] 0 0
Finistere
Country [69] 0 0
France
State/province [69] 0 0
Gironde
Country [70] 0 0
France
State/province [70] 0 0
Ille-et-Vilaine
Country [71] 0 0
France
State/province [71] 0 0
Loire Atlantique
Country [72] 0 0
France
State/province [72] 0 0
Meurthe Et Moselle
Country [73] 0 0
France
State/province [73] 0 0
Nord
Country [74] 0 0
France
State/province [74] 0 0
Val De Marne
Country [75] 0 0
Germany
State/province [75] 0 0
Baden Wuerttemberg
Country [76] 0 0
Germany
State/province [76] 0 0
Bayern
Country [77] 0 0
Germany
State/province [77] 0 0
Hessen
Country [78] 0 0
Germany
State/province [78] 0 0
Nordrhein Westfalen
Country [79] 0 0
Germany
State/province [79] 0 0
Thueringen
Country [80] 0 0
Germany
State/province [80] 0 0
Dresden
Country [81] 0 0
Hungary
State/province [81] 0 0
Budapest
Country [82] 0 0
Hungary
State/province [82] 0 0
Csongrád-Csanád
Country [83] 0 0
Hungary
State/province [83] 0 0
Gyor-Moson-Sopron
Country [84] 0 0
Hungary
State/province [84] 0 0
Somogy
Country [85] 0 0
Hungary
State/province [85] 0 0
Szabolcs-Szatmár-Bereg
Country [86] 0 0
Israel
State/province [86] 0 0
Central
Country [87] 0 0
Israel
State/province [87] 0 0
Southern
Country [88] 0 0
Israel
State/province [88] 0 0
Haifa
Country [89] 0 0
Israel
State/province [89] 0 0
Jerusalem
Country [90] 0 0
Israel
State/province [90] 0 0
Tel Aviv
Country [91] 0 0
Italy
State/province [91] 0 0
Milano
Country [92] 0 0
Italy
State/province [92] 0 0
Roma
Country [93] 0 0
Italy
State/province [93] 0 0
Brescia
Country [94] 0 0
Italy
State/province [94] 0 0
Firenze
Country [95] 0 0
Italy
State/province [95] 0 0
Genova
Country [96] 0 0
Italy
State/province [96] 0 0
Siena
Country [97] 0 0
Japan
State/province [97] 0 0
Aichi-Ken
Country [98] 0 0
Japan
State/province [98] 0 0
Aomori-Ken
Country [99] 0 0
Japan
State/province [99] 0 0
Chiba-Ken
Country [100] 0 0
Japan
State/province [100] 0 0
Fukuoka-Ken
Country [101] 0 0
Japan
State/province [101] 0 0
Fukushima-Ken
Country [102] 0 0
Japan
State/province [102] 0 0
Gifu-Ken
Country [103] 0 0
Japan
State/province [103] 0 0
Hiroshima-Ken
Country [104] 0 0
Japan
State/province [104] 0 0
Hokkaido
Country [105] 0 0
Japan
State/province [105] 0 0
Hyogo-Ken
Country [106] 0 0
Japan
State/province [106] 0 0
Ibaraki-Ken
Country [107] 0 0
Japan
State/province [107] 0 0
Iwate-Ken
Country [108] 0 0
Japan
State/province [108] 0 0
Kanagawa-Ken
Country [109] 0 0
Japan
State/province [109] 0 0
Miyagi-Ken
Country [110] 0 0
Japan
State/province [110] 0 0
Okayama-Ken
Country [111] 0 0
Japan
State/province [111] 0 0
Osaka Prefecture
Country [112] 0 0
Japan
State/province [112] 0 0
Osaka-Fu
Country [113] 0 0
Japan
State/province [113] 0 0
Saitama-Ken
Country [114] 0 0
Japan
State/province [114] 0 0
Tokyo-To
Country [115] 0 0
Japan
State/province [115] 0 0
Wakayama-Ken
Country [116] 0 0
Japan
State/province [116] 0 0
Yamaguchi-Ken
Country [117] 0 0
Japan
State/province [117] 0 0
Yamanashi-Ken
Country [118] 0 0
Korea, Republic of
State/province [118] 0 0
Gyeonggi-do
Country [119] 0 0
Korea, Republic of
State/province [119] 0 0
Gyeongsangnam-do
Country [120] 0 0
Korea, Republic of
State/province [120] 0 0
Busan
Country [121] 0 0
Korea, Republic of
State/province [121] 0 0
Seoul
Country [122] 0 0
Lithuania
State/province [122] 0 0
Kaunas
Country [123] 0 0
Lithuania
State/province [123] 0 0
Vilnius
Country [124] 0 0
Portugal
State/province [124] 0 0
Aveiro
Country [125] 0 0
Portugal
State/province [125] 0 0
Porto
Country [126] 0 0
Portugal
State/province [126] 0 0
Setubal
Country [127] 0 0
Portugal
State/province [127] 0 0
Coimbra
Country [128] 0 0
Portugal
State/province [128] 0 0
Lisboa
Country [129] 0 0
Russian Federation
State/province [129] 0 0
Leningrad
Country [130] 0 0
Russian Federation
State/province [130] 0 0
Respublka Tatarstan
Country [131] 0 0
Russian Federation
State/province [131] 0 0
Krasnodar
Country [132] 0 0
Russian Federation
State/province [132] 0 0
Moscow
Country [133] 0 0
Spain
State/province [133] 0 0
Barcelona
Country [134] 0 0
Spain
State/province [134] 0 0
Córdoba
Country [135] 0 0
Spain
State/province [135] 0 0
La Coruña
Country [136] 0 0
Spain
State/province [136] 0 0
Málaga
Country [137] 0 0
Spain
State/province [137] 0 0
Girona
Country [138] 0 0
Spain
State/province [138] 0 0
Madrid
Country [139] 0 0
Spain
State/province [139] 0 0
Sevilla
Country [140] 0 0
Spain
State/province [140] 0 0
Valencia
Country [141] 0 0
Spain
State/province [141] 0 0
Valladolid
Country [142] 0 0
Switzerland
State/province [142] 0 0
Ticino
Country [143] 0 0
Switzerland
State/province [143] 0 0
Bern
Country [144] 0 0
Taiwan
State/province [144] 0 0
Kaohsiung
Country [145] 0 0
Taiwan
State/province [145] 0 0
Tainan
Country [146] 0 0
Taiwan
State/province [146] 0 0
Taipei
Country [147] 0 0
Taiwan
State/province [147] 0 0
Taoyuan
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Cambridgeshire
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Greater London
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Nottinghamshire
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Strathclyde
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Tyne & Wear

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
Biogen
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