ischemic stroke MedDRA version: 9.1 Level: LLT Classification code 10061256 Term: Ischaemic stroke
Conditions
Interventions
Product Name: AX200
Product Code: AX200
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Filgrastim
CAS Number: 121181-53-1
Current Sponsor code: AX200
Concentration unit: µg/ml microgr
Sponsors
SYGNIS Bioscience GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 or prestroke BI 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 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 hours 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 or 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) · Patients with a history of active substance abuse (including alcohol) for the last 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the present study is to assess efficacy of AX200 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. | — |
Countries
Austria, Belgium, Czech Republic, Germany, Poland, Slovakia, Spain, Sweden
Outcome results
None listed