Study to evaluate the use of the investigational drug BIIB093 versus placebo in patients with a large hemispheric infarction.
- Conditions
- Cerebral edema following Large Hemispheric InfarctionMedDRA version: 20.0Level: LLTClassification code 10008107Term: Cerebral edemaSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-004854-41-GB
- Lead Sponsor
- Biogen Idec Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 768
1. Ability to understand the purpose and risks of the study and provide
signed and dated informed consent and authorization to use confidential
health information in accordance with national and local subject privacy
regulations or consent provided by an independent physician where local
regulation allows, and/or provision of informed consent by the subject's
legally authorized representative (LAR) in accordance with all local and
national regulations or according to the local ethics committee's
guidelines or by another process compliant with applicable national laws
and regulations and ethics committee requirements.
2. A clinical diagnosis of acute ischemic stroke in the MCA territory (PCA
and/or ACA territory involvement in addition to primary MCA territory
stroke is acceptable).
3. Aged 18 to 85 years old, inclusive, at the time of informed consent.
4. Screening NIHSS =10.
5. Prior to the current stroke, no significant disability in the opinion of
the Investigator (able to independently perform all duties and activities
of daily living without assistance from a caregiver, spouse, or another
person).
6. A large hemispheric infarction defined, in order of preference, as
either:
a)a magnetic resonance imaging (MRI) diffusion-weighted imaging
(DWI) lesion volume of 80 to 300 cm3, or
b)a computed tomography perfusion (CTP) core lesion volume of 80 to
300 cm3, or
c)an Alberta Stroke Program Early computed tomography (CT) Score
(ASPECTS) on non-contrast computed tomography (NCCT) of 1 to 5 with
involvement of at least 2 defined cortical regions, if lesion volume from
MRI DWI or CTP is not available.
In the event that more than one scan is available for a particular subject
resulting in disagreement, the investigator should make the
determination about eligibility considering all patient information
including but not limited to: 1) scan timing and 2) scan modality that in
the opinion of the investigator best represents the infarct size. The scan
used for eligibility will be documented
7. For subjects who receive thrombectomy prior to randomization,
inclusion into the study must be based on an infarct volume of 80 to 300
cm3 measured by post-thrombectomy MRI-DWI.
8. At the time of randomization and in the Investigator's judgment, 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 (if time to symptom onset is unknown). Investigators
should refer to Section 11.1.
• Subjects who wake with stroke may be included if neurological and
other exclusion criteria are satisfied. These wake up strokes are
defined as having no symptoms at sleep onset and a known sleep onset
time, but stroke symptoms on waking. The time of stroke onset is to be
taken as the midpoint between sleep onset and time of waking. The
maximum time window for initiation of study drug treatment infusion is
then 10 hours from the midpoint as described. If sleep onset time is
unknown, then last known normal time must be used and the midpoint
does not apply.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 268
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method