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

Acute Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756249
• Other study ID #: 11767A
• Secondary ID: 2006-005959-15
• Status: Completed
• Phase: Phase 1
• First received: September 19, 2008
• Last updated: September 24, 2010
• Start date: October 2007
• Est. completion date: December 2008

Study information

• Verified date: September 2010
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyFrance: 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 AuthorityUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Stroke

Intervention

Drug:
• Lu AA24493 (CEPO)
0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
• Placebo
Vials with solution for IV infusion

Locations

Country	Name	City	State
Finland	FI004	Helsinki
France	FR002	Paris
Netherlands	NL005	Breda
Singapore	SG003	Singapore
United Kingdom	GB001	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Finland,  France,  Netherlands,  Singapore,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No