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

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Lu AA24493 (CEPO)
Placebo
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Acute ischemic stroke, Erythropoietin, Carbamylated, Neuroprotection

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • FI004
  • FR002
  • NL005
  • SG003
  • GB001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Lu AA24493 (CEPO): 0.005 mcg/kg

Lu AA24493 (CEPO): 0.05 mcg/kg

Lu AA24493 (CEPO): 0.5 mcg/kg

Lu AA24493 (CEPO): 5.0 mcg/kg

Lu AA24493 (CEPO): 50.0 mcg/kg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS)

Secondary Outcome Measures

Pharmacokinetics, immunogenicity and mechanistic biomarkers (S-100b, glial fibrillary acidic protein (GFAP), matrix metalloproteinase 9 (MMP-9))

Full Information

First Posted
September 19, 2008
Last Updated
September 24, 2010
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00756249
Brief Title
Safety Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Acute ischemic stroke, Erythropoietin, Carbamylated, Neuroprotection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lu AA24493 (CEPO): 0.005 mcg/kg
Arm Type
Experimental
Arm Title
Lu AA24493 (CEPO): 0.05 mcg/kg
Arm Type
Experimental
Arm Title
Lu AA24493 (CEPO): 0.5 mcg/kg
Arm Type
Experimental
Arm Title
Lu AA24493 (CEPO): 5.0 mcg/kg
Arm Type
Experimental
Arm Title
Lu AA24493 (CEPO): 50.0 mcg/kg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lu AA24493 (CEPO)
Intervention Description
0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vials with solution for IV infusion
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
FI004
City
Helsinki
ZIP/Postal Code
00029 HUS
Country
Finland
Facility Name
FR002
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
NL005
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
SG003
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
GB001
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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