Safety Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke
Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Lu AA24493 in Acute Ischemic Stroke
2 other identifiers
interventional
16
5 countries
5
Brief Summary
The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO) 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 below P25 for phase_1
Started Oct 2007
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 19, 2008
CompletedFirst Posted
Study publicly available on registry
September 22, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedSeptember 27, 2010
September 1, 2010
11 months
September 19, 2008
September 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS)
Baseline, Day 7, Day 30; for NIHSS also Day 2 and 3
Secondary Outcomes (1)
Pharmacokinetics, immunogenicity and mechanistic biomarkers (S-100b, glial fibrillary acidic protein (GFAP), matrix metalloproteinase 9 (MMP-9))
Baseline, Day 1-4, Day 7 and Day 30
Study Arms (6)
Lu AA24493 (CEPO): 0.005 mcg/kg
EXPERIMENTALLu AA24493 (CEPO): 0.05 mcg/kg
EXPERIMENTALLu AA24493 (CEPO): 0.5 mcg/kg
EXPERIMENTALLu AA24493 (CEPO): 5.0 mcg/kg
EXPERIMENTALLu AA24493 (CEPO): 50.0 mcg/kg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
0.005 - 50.0 mcg/kg body weight, IV, within 12-48 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 12 hours and 48 hours after the onset of stroke
- Expected hospital stay of at least 72 hours after 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 excluded ICH then eligible)
- Score \>0 on the NIHSS item 1a
- Pre-stroke mRS score \>1
- Uncontrolled hypertension
- Previous treatment with erythropoietin
- Clinically significant abnormal ECG
- Cerebral pathology
- Received or donated blood within previous 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (5)
FI004
Helsinki, 00029 HUS, Finland
FR002
Paris, 75018, France
NL005
Breda, 4818 CK, Netherlands
SG003
Singapore, 119074, 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
September 19, 2008
First Posted
September 22, 2008
Study Start
October 1, 2007
Primary Completion
September 1, 2008
Study Completion
December 1, 2008
Last Updated
September 27, 2010
Record last verified: 2010-09