Safety Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke - Full Text View

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 (Adult, Senior)
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


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:


Stroke Ischemia Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases	Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Epoetin Alfa Hematinics

ClinicalTrials.gov processed this record on September 29, 2016