Acute Ischemic StrokePhase 1NCT00756249
Safety Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke
A Phase 1 study testing Lu AA24493 (CEPO) in people with Acute Ischemic Stroke, run by H. Lundbeck A/S at 5 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Lu AA24493 (CEPO)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Oct 2007to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Clinically significant abnormal ECG
- Cerebral pathology
- Received or donated blood within previous 3 months
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
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
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Lu AA24493 (CEPO), Placebo
- Keywords
- Acute ischemic stroke, Erythropoietin, Carbamylated, Neuroprotection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AA24493 (CEPO)Drug
0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
PlaceboDrug
Vials with solution for IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Lu AA24493 (CEPO): 0.005 mcg/kg | Experimental | Not described Receives: Drug: Lu AA24493 (CEPO) |
| Lu AA24493 (CEPO): 0.05 mcg/kg | Experimental | Not described Receives: Drug: Lu AA24493 (CEPO) |
| Lu AA24493 (CEPO): 0.5 mcg/kg | Experimental | Not described Receives: Drug: Lu AA24493 (CEPO) |
| Lu AA24493 (CEPO): 5.0 mcg/kg | Experimental | Not described Receives: Drug: Lu AA24493 (CEPO) |
| Lu AA24493 (CEPO): 50.0 mcg/kg | Experimental | Not described Receives: Drug: Lu AA24493 (CEPO) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS)
Measured: Baseline, Day 7, Day 30; for NIHSS also Day 2 and 3
Secondary outcomes (1)
Pharmacokinetics, immunogenicity and mechanistic biomarkers (S-100b, glial fibrillary acidic protein (GFAP), matrix metalloproteinase 9 (MMP-9))
Measured: Baseline, Day 1-4, Day 7 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startOct 2007
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756249
- Sponsor's protocol ID
- 11767A
- Other IDs
- 2006-005959-15
- Status last verified
- Sep 2010
- First submitted
- 19 Sep 2008
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00756249
- Acronym / sponsor ID
- 11767A
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, Erythropoietin, Carbamylated, Neuroprotection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Lu AA24493 (CEPO): 0.005 mcg/kg | Experimental | Drug: Lu AA24493 (CEPO) |
| Lu AA24493 (CEPO): 0.05 mcg/kg | Experimental | Drug: Lu AA24493 (CEPO) |
| Lu AA24493 (CEPO): 0.5 mcg/kg | Experimental | Drug: Lu AA24493 (CEPO) |
| Lu AA24493 (CEPO): 5.0 mcg/kg | Experimental | Drug: Lu AA24493 (CEPO) |
| Lu AA24493 (CEPO): 50.0 mcg/kg | Experimental | Drug: Lu AA24493 (CEPO) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AA24493 (CEPO)0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset | Drug | 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 |
| PlaceboVials with solution for IV infusion | Drug | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lu AA24493 (CEPO) in people with Acute Ischemic Stroke, run by H. Lundbeck A/S at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland, France, Netherlands, Singapore, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2010.