AXIS 2: AX200 for the Treatment of Ischemic Stroke (AXIS-2)
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ClinicalTrials.gov Identifier: NCT00927836 |
Recruitment Status :
Completed
First Posted : June 25, 2009
Last Update Posted : December 13, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Ischemic Stroke | Biological: Filgrastim Drug: Sodium chloride solution | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 328 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | AXIS 2: AX200 for the Treatment of Ischemic Stroke - A Multinational, Multicenter, Randomized, Doubleblind, Placebo-controlled Phase II Trial |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | November 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: AX200 |
Biological: Filgrastim
135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days |
Placebo Comparator: Placebo |
Drug: Sodium chloride solution
Short term infusion (20 to 30 minutes) and continuous infusion over 3 days |
- Improvement on mRS relative to placebo-treated patients [ Time Frame: day 90 ]
- Improvement on NIHSS relative to placebo-treated patients [ Time Frame: day 90 ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927836

Study Chair: | Frank Rathgeb, Dr. | Sygnis Bioscience GmbH & Co KG | |
Study Director: | Rico Laage, Dr. | Sygnis Bioscience GmbH & Co KG |
Responsible Party: | Sygnis Bioscience GmbH & Co KG |
ClinicalTrials.gov Identifier: | NCT00927836 |
Other Study ID Numbers: |
AX200-101 EudraCT 2008-006444-19 |
First Posted: | June 25, 2009 Key Record Dates |
Last Update Posted: | December 13, 2011 |
Last Verified: | August 2011 |
Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Lenograstim Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |