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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lu AA24493 (CEPO): 0.5 mcg/kg

Group Type EXPERIMENTAL

Lu AA24493 (CEPO)

Intervention Type DRUG

0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset

Lu AA24493 (CEPO): 5.0 mcg/kg

Group Type EXPERIMENTAL

Lu AA24493 (CEPO)

Intervention Type DRUG

0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset

Lu AA24493 (CEPO): 50.0 mcg/kg

Group Type EXPERIMENTAL

Lu AA24493 (CEPO)

Intervention Type DRUG

0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vials with solution for IV infusion

Interventions

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Lu AA24493 (CEPO)

0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset

Intervention Type DRUG

Placebo

Vials with solution for IV infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No