AXIS 2: AX200 for the treatment of ischemic strokeA multinational, multicenter, randomized, doubleblind,placebo-controlled, phase II trial

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 328

Inclusion Criteria

All of the following inclusion criteria need to be fulfilled:
· Diagnosis of acute ischemic stroke with an onset within 9 hours prior to
start of study agent administration.
· ischemic stroke in the MCA territory confirmed by MRI (diffusion)
· men and women aged = 18 years and = 85 years
· NIHSS score = 6 and =22
· lesion size on DWI: on the slice showing the largest extension of the
infarct the largest diameter of the lesion should have at least 3 cm and
should show on at least 3 consecutive slices; if the rule cannot be
applied (e.g. due to an irregular shape or partially separate volumes on
the slice), but in the clinical judgment the lesion is = 15 cm3, the patient
should be included in the clinical study if the investigator can provide a
written justification
· written informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients meeting any of the following criteria will be excluded from randomization:
· Participation in another study with an investigational drug or device within
the last 30 days or planned participation in another trial
· Prior to current stroke: Inability to walk or to lead an independent life; prestroke
BI score < 95 or pre-stroke mRS score > 1
· Life expectancy considered to be less or equal 6 months in the judgment
of the investigator
· Neurological deficit that has led to stupor or coma (suspicious of
malignant hemispheric stroke)
· Infarct is lacunar
· Any evidence of ICH by imaging.Patients with cerebral micro-bleedings can be included in the study.
· Current malignant hypertension with systolic and diastolic blood pressure
> 220 mmHg and > 120 mmHg, respectively
· Strong clinical suspicion of septic embolus
· Any thrombosis involving the cerebral veins
· High clinical suspicion of vasculitis (e.g. multiple caliber irregularities of
intracerebral vessels on MRA plus history of vasculitis)
· Any MRI finding indicating that there might be a non-vascular cause for
the present neurological symptoms
· Any signs on imaging of a mass effect causing shift of midline structures
· Presence or history of active malignancies within one year preceding
randomization, especially
hematological malignancies or
myeloproliferative diseases
· A platelet count < 100 /nl at V0
· A leukocyte count >20 /nl at V0
· Congenital neutropenia
· Other serious illness, e.g., severe hepatic, cardiac, or renal failure, acute
myocardial infarction or a complex disease that may confound treatment
assessment
· Any suspected hypersensitivity and/or contraindication to any ingredients
of the study medication
· Patients currently receiving G-CSF or GM-CSF
· Thrombolytic drug treatment outside the recommendations of the current ESO Guidelines for Management of Ischemic Stroke and Transient Ischemic Attack 200, especially if the treatment was initiated > 4.5 hrs after stroke onset, or the patient had recent severe or dangerous bleeding prior treatment, or despite anticoagulant or heparin treatment.
· Patients for which any of the following treatments are planned for acute recanalisation of intracranial vessels:use of mechanical devices for clot retraction like the Merci Retriever of the Penumbra System, or any vessel dilation or stenting procedure.
· Pregnant or lactating women (for women of childbearing potential a
negative serum pregnancy test is required at V0). Women of childbearing potential that have not used an acceptable method of contraception (e.g. hormonal implants, injectables, combined oral contraceptives, intrauterine devices (IUDs) within one month prior to entry into the study.
· Patients with a history of active substance abuse (including alcohol) for
the last 2 years

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the present study is to assess efficacy of AX200<br>compared to placebo in patients suffering from acute stroke.;Secondary Objective: The secondary objective is to assess safety and tolerability of AX200.;Primary end point(s): Improvement on continuous mRS relative to placebo-treated patients.

Secondary Outcome Measures

Name	Time	Method

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