MedDataX Logo

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

NCT ID: NCT00756249

Last Updated: 2010-09-27

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lu AA24493 (CEPO): 0.005 mcg/kg

Group Type EXPERIMENTAL

Lu AA24493 (CEPO)

Intervention Type DRUG

0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset

Lu AA24493 (CEPO): 0.05 mcg/kg

Group Type EXPERIMENTAL

Lu AA24493 (CEPO)

Intervention Type DRUG

0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset

Lu AA24493 (CEPO): 0.5 mcg/kg

Group Type EXPERIMENTAL

Lu AA24493 (CEPO)

Intervention Type DRUG

0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset

Lu AA24493 (CEPO): 5.0 mcg/kg

Group Type EXPERIMENTAL

Lu AA24493 (CEPO)

Intervention Type DRUG

0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset

Lu AA24493 (CEPO): 50.0 mcg/kg

Group Type EXPERIMENTAL

Lu AA24493 (CEPO)

Intervention Type DRUG

0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vials with solution for IV infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lu AA24493 (CEPO)

0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset

Intervention Type DRUG

Placebo

Vials with solution for IV infusion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

H. Lundbeck A/S

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

FI004

Helsinki, , Finland

Site Status

FR002

Paris, , France

Site Status

NL005

Breda, , Netherlands

Site Status

SG003

Singapore, , Singapore

Site Status

GB001

Glasgow, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland France Netherlands Singapore United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2006-005959-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11767A

Identifier Type: -

Identifier Source: org_study_id