Safety and Pharmacokinetic 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:
NCT00870844
First received: March 26, 2009
Last updated: April 19, 2011
Last verified: April 2011
  Purpose

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.


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: 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

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: NIHSS = Baseline: Day 2, 3, 4, 5, Day 6/Discharge, Day 14, 30. mRS = Baseline, Day 6/Discharge, Day 14, 30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics, immunogenicity and biomarkers [ Time Frame: Baseline, Days 1-6, Day 30 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2009
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lu AA24493 (CEPO): 0.5 mcg/kg Drug: Lu AA24493 (CEPO)
0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset
Experimental: Lu AA24493 (CEPO): 5.0 mcg/kg Drug: Lu AA24493 (CEPO)
0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset
Experimental: Lu AA24493 (CEPO): 50.0 mcg/kg Drug: Lu AA24493 (CEPO)
0.5 to 50.0 mcg/kg body weight, IV, within 0 to 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. 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. 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.

  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 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

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 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
  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: NCT00870844

Locations
Finland
FI004
Helsinki, Finland, 29
France
FR002
Paris, France, 75018
Netherlands
NL005
Breda, Netherlands, 4818 CK
Singapore
SG003
Singapore, Singapore
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: NCT00870844     History of Changes
Other Study ID Numbers: 12053A, 2007-003390-81
Study First Received: March 26, 2009
Last Updated: April 19, 2011
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