Safety Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke

This study has been completed.
Sponsor:
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00756249
First received: September 19, 2008
Last updated: September 24, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Acute Ischemic Stroke
Drug: Lu AA24493 (CEPO)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Lu AA24493 in Acute Ischemic Stroke

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS) [ Time Frame: Baseline, Day 7, Day 30; for NIHSS also Day 2 and 3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics, immunogenicity and mechanistic biomarkers (S-100b, glial fibrillary acidic protein (GFAP), matrix metalloproteinase 9 (MMP-9)) [ Time Frame: Baseline, Day 1-4, Day 7 and Day 30 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lu AA24493 (CEPO): 0.005 mcg/kg Drug: Lu AA24493 (CEPO)
0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
Experimental: Lu AA24493 (CEPO): 0.05 mcg/kg Drug: Lu AA24493 (CEPO)
0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
Experimental: Lu AA24493 (CEPO): 0.5 mcg/kg Drug: Lu AA24493 (CEPO)
0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
Experimental: Lu AA24493 (CEPO): 5.0 mcg/kg Drug: Lu AA24493 (CEPO)
0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
Experimental: Lu AA24493 (CEPO): 50.0 mcg/kg Drug: Lu AA24493 (CEPO)
0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
Placebo Comparator: Placebo Drug: Placebo
Vials with solution for IV infusion

Detailed Description:

Acute ischemic stroke is a major cause of death and severe disability. There is only one approved pharmacological treatment, Alteplase, which has to be administered within 3 hours from symptom onset. Consequently, only about 2-3% of patients world wide with ischemic strokes are treated. The naturally occurring hormone, erythropoietin (EPO), is able to protect various neuronal tissues from ischemic injury and is beneficial in animal models of acute ischemic stroke. However, treatment of stroke with EPO is undesirable due to its ability to stimulate production of red blood cells and to promote the blood to coagulate. Lu AA24493 is a modified (carbamylated) version of EPO, neuroprotective but without the haematopoietic side effects. Lu AA24493 is developed for treatment of patients with acute ischemic stroke.

In this safety study of single doses with Lu AA24493, patients will receive Lu AA24493 within 12-48 hours from symptom onset.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756249

Locations
Finland
FI004
Helsinki, Finland, 00029 HUS
France
FR002
Paris, France, 75018
Netherlands
NL005
Breda, Netherlands, 4818 CK
Singapore
SG003
Singapore, Singapore, 119074
United Kingdom
GB001
Glasgow, United Kingdom, G11 6NT
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00756249     History of Changes
Other Study ID Numbers: 11767A, 2006-005959-15
Study First Received: September 19, 2008
Last Updated: September 24, 2010
Health Authority: Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Singapore: Health Sciences Authority
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by H. Lundbeck A/S:
Acute ischemic stroke
Erythropoietin
Carbamylated
Neuroprotection

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 16, 2014