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EUCTR2017-004854-41
Alternative entry with additional local information: NCT02864953

Study to evaluate the use of the investigational drug BIIB093 versus placebo in patients with a large hemispheric infarction.

Data source: WHO (Imported from 02.08.2020)
Changed: 02.08.2020
Disease category:

Health conditions (Data source: WHO)

Cerebral edema following Large Hemispheric Infarction
MedDRA version: 20.0Level: LLTClassification code 10008107Term: Cerebral edemaSystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Interventions (Data source: WHO)


Product Name: BIIB093(Glibenclamide)
Product Code: BIIB093
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: GLIBENCLAMIDE
CAS Number: 10238-21-8
Current Sponsor code: BIIB093
Other descriptive name: Glyburide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Powder for concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Inclusion/Exclusion Criteria (Data source: WHO)

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. Study treatment infusion within 10 hours after time of symptom onset, if known, or the time last known normal
5. For participants who receive thrombectomy, inclusion into the study must be based on post-thrombectomy MRI-DWI

NOTE: Other protocol defined Inclusion criteria may apply

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 102
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 578

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1.Participant is likely to have supportive care withdrawn on the first day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 Exclusion criteria may apply

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004854-41

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2017-004854-41-DE

Further information on trial

Date trial registered

08.06.2018

Incorporation of the first participant

18.12.2018

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

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 - CHARM

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2

Phase (Data source: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Primary end point (Data source: WHO)

Main Objective: The primary objective 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).;Secondary Objective: The secondary objectives 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. ;Primary end point(s): Proportion of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS);Timepoint(s) of evaluation of this end point: Baseline up to Day 90

Secundary end point (Data source: WHO)

Secondary end point(s): 1.Time to All-Cause Death [ Time Frame: Baseline up to Day 90 ]
2.Proportion of Participants who achieved mRS 0-4 at Day 90 [Time Frame: Baseline up to Day 90]
3.Reduction in Midline Shift at 72 Hours [ Time Frame: Baseline up to 72 Hours]
4.Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 90]
;Timepoint(s) of evaluation of this end point: #’s 1, 2 & 4 (Baseline up to Day 90)
#3 (Baseline up to 72 hours)

Contact information (Data source: WHO)

Biogen Idec Reseach Limited

Trial results (Data source: WHO)

Results summary

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

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, Germany, Hungary, Israel, Japan, Korea, Lithuania, Mexico, Portugal, Republic of, Russian Federation, Spain, Switzerland, Taiwan, United Kingdom, United States

Contact for further information on the trial

Contact for general information (Data source: WHO)

Medical Director/Monitor
Innovation House, 70 Norden Road
Biogen
ClinicialTrials@biogen.com

Contact for scientific information (Data source: WHO)

Medical Director/Monitor
Innovation House, 70 Norden Road
Biogen
ClinicialTrials@biogen.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Biogen Idec Research Limited

Further trial identification numbers

Secondary ID (Data source: WHO)

252LH301
NCT02864953
2017-004854-41-GB