Safety and Pharmacokinetic Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke
A Randomised, Double-blind, Placebo-controlled, Multiple-dose, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Lu AA24493 in Patients With Acute Ischemic Stroke
2 other identifiers
interventional
24
5 countries
5
Brief Summary
The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO) dosed once daily for 5 days is a safe treatment for patients who have suffered an acute ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2009
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 27, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedApril 20, 2011
April 1, 2011
1.6 years
March 26, 2009
April 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS)
NIHSS = Baseline: Day 2, 3, 4, 5, Day 6/Discharge, Day 14, 30. mRS = Baseline, Day 6/Discharge, Day 14, 30
Secondary Outcomes (1)
Pharmacokinetics, immunogenicity and biomarkers
Baseline, Days 1-6, Day 30
Study Arms (4)
Lu AA24493 (CEPO): 0.5 mcg/kg
EXPERIMENTALLu AA24493 (CEPO): 5.0 mcg/kg
EXPERIMENTALLu AA24493 (CEPO): 50.0 mcg/kg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset
Eligibility Criteria
You may qualify if:
- Age between 50 and 90 years
- Clinical diagnosis of acute ischemic stroke
- Measurable stroke-related deficit
- Patient is stable
- Treatment can be initiated between 0 hours and 48 hours after the onset of stroke
- Expected hospital stay of at least 120 hours after first dose of study medication
- If female then not of childbearing potential
You may not qualify if:
- Primary intracerebral haemorrhage (ICH), or parenchymal haemorrhagic transformation of infarction (type PHI or PHII as defined in ECASS), subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), cerebral aneurysm, or cerebral neoplasm
- Treated with a thrombolytic \<24 hours (if \>24 hours and excluded ICH then eligible)
- Score \>=1 on the NIHSS item 1a
- Pre-stroke mRS score \>=2
- Uncontrolled hypertension
- Previous treatment with erythropoietin
- Previous exposure to Lu AA24493
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (5)
FI004
Helsinki, 29, Finland
FR002
Paris, 75018, France
NL005
Breda, 4818 CK, Netherlands
SG003
Singapore, Singapore
GB001
Glasgow, G11 6NT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 26, 2009
First Posted
March 27, 2009
Study Start
May 1, 2009
Primary Completion
December 1, 2010
Study Completion
March 1, 2011
Last Updated
April 20, 2011
Record last verified: 2011-04