AXIS 2: AX200 for the Treatment of Ischemic Stroke (AXIS-2)

Sygnis Bioscience

Status and phase: Completed; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Biological: Filgrastim; Drug: Sodium chloride solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00927836

EudraCT 2008-006444-19

AX200-101

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of AX200 (filgrastim) in the treatment of acute ischemic stroke and to assess the safety and tolerability of AX200.

Enrollment: 328 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

• 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)
• age ≥18 years and ≤85 years
• lesion size on DWI ≥15 ccm
• written informed consent

Major Exclusion Criteria:

• prior to current stroke: inability to walk or to lead an independent life
• life expectancy less or equal 6 months
• stupor or coma
• lacunar infarct
• any evidence of ICH
• malignant hypertension
• presence of history of active malignancies
• platelet count <100/nl at randomization
• leukocyte count >20/nl at randomization
• congenital neutropenia
• pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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328 participants in 2 patient groups, including a placebo group

AX200

Experimental group

Treatment:

Biological: Filgrastim

Placebo

Placebo Comparator group

Treatment:

Drug: Sodium chloride solution