AXIS 2: AX200 for the Treatment of Ischemic Stroke

NCT00927836 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2011-12-13

No results posted yet for this study

Summary

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.

Conditions

  • Acute Ischemic Stroke

Interventions

BIOLOGICAL

Filgrastim

135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days

DRUG

Sodium chloride solution

Short term infusion (20 to 30 minutes) and continuous infusion over 3 days

Sponsors & Collaborators

  • Sygnis Bioscience GmbH & Co KG

    lead INDUSTRY

Principal Investigators

  • Frank Rathgeb, Dr. · Sygnis Bioscience GmbH & Co KG

  • Rico Laage, Dr. · Sygnis Bioscience GmbH & Co KG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Austria
  • Belgium
  • Czechia
  • Germany
  • Poland
  • Slovakia
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00927836 on ClinicalTrials.gov