Stroke, AcutePhase 2NCT00123305
Intravenous Administration of Microplasmin for Treatment of Acute Ischemic Stroke
A Phase 2 study testing Microplasmin in people with Stroke, Acute, run by ThromboGenics at 16 sites in 3 countries.
Trial summary
The primary purpose of this study is to evaluate the safety and preliminary efficacy of microplasmin when administered intravenously to patients who have suffered an acute stroke within 12 hours before randomization. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Microplasmin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Oct 2005to Jun 2008
- Phase
- Phase 2
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke with onset within 12 hours before randomization with baseline NIHSS > 6 and < 22
Who cannot join
- General Exclusion Criteria
- Participation in another study with an investigational drug or device within the previous 30 days, prior participation in the present study, or planned participation in another trial within the time frame of the current trial
- Symptoms suggestive of subarachnoid hemorrhage, even if CT scan or MRI is negative for hemorrhage
- Women known to be pregnant, lactating, or having a positive or indeterminate pregnancy test
- Stroke Related Exclusion Criteria
- Neurological deficit that has led to stupor or coma (National Institutes of Health Stroke Scale [NIHSS] Level Of Consciousness Item 1a score >or=2)
Show all 39Show fewer
- High clinical suspicion of septic embolus
- Thrombosis involving cerebral veins
- Rapidly improving neurological signs at any time before initiation of study drug administration
- Imaging Related Exclusion Criteria
- Hemorrhagic transformation or intracerebral hemorrhage observed on baseline CT of the brain or gradient recalled echo (GRE) magnetic resonance imaging
- CT or MRI evidence of nonvascular cause for the neurological symptoms
- Large hypodensity on CT involving > 1/3 of the middle cerebral artery (MCA) territory
- Baseline DWI volume > 1/3 of the MCA territory
- Signs of mass effect causing shift of midline structures on CT or MRI
- Unable to undergo MRI (i.e., ferrous implants, cardiac pacemakers, agitation, claustrophobia or known sensitivity to MRI contrast agents)
- Safety Related Exclusion Criteria
- Congenital or acquired coagulopathy causing either of the following
- activated partial thromboplastin time prolongation greater than 2 seconds above the upper limit of normal (ULN) for local laboratory
- International normalized ratio (INR) of 1.4 or more.
- Uncontrolled hypertension defined as a systolic blood pressure > 180 mm Hg or a diastolic blood pressure > 100 mm Hg on 3 separate occasions at least 10 minutes apart or requiring continuous intravenous (IV) therapy.
- History of stroke within the previous 3 months
- Seizures at any time between stroke onset to planned initiation of study drug
- History of intracranial hemorrhage
- History of surgery, lumbar puncture, biopsy or trauma to internal organs within the previous 30 days.
- Major trauma at the time of stroke
- Head trauma within the previous 90 days.
- Known bleeding diathesis.
- Baseline platelet count < 100 X 10^9/L.
- Blood glucose > 400mg/dl or <50 mg/dl if administration of glucose does not rapidly reverse neurological deficit
- Exclusion Criteria That May Potentially Interfere with Outcome Assessment
- Life expectancy <3 months
- Other serious illness that in the opinion of the investigator may confound clinical assessment (e.g. hepatic, cardiac, or renal failure, advanced cancer)
- If treatment with tPA is indicated
- Treatment with rtPA or any other thrombolytic agent for the qualifying stroke
- Administration of intra-arterial or systemic thrombolytic therapy in previous 7 days
- Need for antiplatelet agent, unfractionated or heparin-related products, direct thrombin inhibitor, oral anticoagulant within 24 hours after treatment bolus.
- Treatment with low molecular weight heparin, direct thrombin inhibitor, or GPIIb/IIIa antagonists within 48 hours prior to randomisation
- Treatment with vitamin-K antagonists or heparin (or heparin-related compounds) which results in either an INR>1.4 or an aPTT>2 times control (ULN for the hospital laboratory)
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Germany10 sites
Universitätsklinikum Erlangen
Erlangen, 91054
Universitatsklinikum Essen
Essen, 45122
Klinikum der J.W Goethe Univeristy
Frankfurt, 60528
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106
Georg August Universitat Gottingen
Göttingen, 37075
Universitatskrankenhaus Hamburg-Eppendorf
Hamburg, 20246
Universitatsklinikum Leipzig
Leipzig, 04103
Klinikum Minden, Chefarzt der Neurologischen Klinik
Minden, 32427
Klinikum rechts der Isar der TU München
München, 81675
HSK Dr. Horst Schmidt Hospital
Wiesbaden, 65199
Austria4 sites
Universitatsklinik fur Neurologie
Graz, 8036
Landesnervenklinik Wagner-Jauregg
Linz, 4020
AKH Linz Neurolog Abt
Linz, A-4020
Allgemeines Offentliches Krankenhaus der
Linz, A-4021
Belgium2 sites
Cliniques Universitaires St Luc
Brussels, 1200
Gasthuisburg Hospital
Leuven, B-3000
About this study
Official title: A Multicentre, Double-Blind, Placebo-Controlled, Ascending-dose, Clinical Trial of Intravenous Microplasmin Administration in Patients With Acute Ischemic Stroke
The primary purpose of this study is to evaluate the safety and preliminary efficacy of microplasmin when administered intravenously to patients who have suffered an acute stroke within 12 hours before randomization.
Read the detailed description
While the primary objective of the trial is safety evaluation, efficacy assessments will also be obtained, including MRI/MRA (including DWI, PWI and T2 imaging) and plasma surrogate biomarkers. Clinical outcome will also be assessed at 7days, 30 days and 90 days post-treatment. At each of these visits, mortality and neurological assessments (NIHSS, Barthel index, mRankin scale) will be performed. In addition, vital status will be assessed vial a telephone contact at 60 days post-treatment.
The trial will investigate three dose regimens of microplasmin, all of which are within the range of doses previously evaluated in a Phase I trial in healthy volunteers; the planned sample size for the trial is approximately 40 patients.
The study will consist of 3 phases - the Baseline, In-hospital Phase and Follow up Phase. Baseline is from study entry through randomisation; the In-hospital phase is from treatment with study drug through hospital discharge or day 7, whichever occurs first. The follow up phase consists of visits to the hospital 30 days (+ 3 days) from the day of study drug administration. Hospital discharge is defined as the end of the discharge from the acute hospital setting. Discharge may be to home, to a rehabilitation setting or to a non-acute hospital setting.
- Conditions
- Stroke, Acute
- Being tested
- Microplasmin
- Keywords
- Stroke, Acute Ischemic Stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroplasminDrug
1mg/kg bolus of microplasmin solution followed by 1,2 or 3mg/kg infusion of mircroplasmin solution.
MicroplasminDrug
1mg/kg bolus of placebo solution followed by 1,2 or 3mg/kg infusion of placebo solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Microplasmin |
| 2 | Experimental | Not described Receives: Drug: Microplasmin |
| 3 | Experimental | Not described Receives: Drug: Microplasmin |
| 4 | Placebo comparator | Not described Receives: Drug: Microplasmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial haemorrhage
Measured: 24 hours and Day-7
Change from Baseline in NIHSS
Measured: Day7 and Day-90
Secondary outcomes (2)
Barthel Index and modified Rankin scale
Measured: Day-90
Markers of systemic lysis
Measured: Baseline, end of treatment, 6, 12, 24, 72 and 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startOct 2005
- Primary completionMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincent Thijs, MD PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123305
- Sponsor's protocol ID
- TG-M-004
- Status last verified
- Nov 2014
- First submitted
- 21 Jul 2005
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Double-Blind, Placebo-Controlled, Ascending-dose, Clinical Trial of Intravenous Microplasmin Administration in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00123305
- Acronym / sponsor ID
- TG-M-004
- Conditions
- Stroke, Acute
- Keywords
- Stroke, Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 22 Jul 2005 (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 this study is to evaluate the safety and preliminary efficacy of microplasmin when administered intravenously to patients who have suffered an acute stroke within 12 hours before randomization.
Detailed description
While the primary objective of the trial is safety evaluation, efficacy assessments will also be obtained, including MRI/MRA (including DWI, PWI and T2 imaging) and plasma surrogate biomarkers. Clinical outcome will also be assessed at 7days, 30 days and 90 days post-treatment. At each of these visits, mortality and neurological assessments (NIHSS, Barthel index, mRankin scale) will be performed. In addition, vital status will be assessed vial a telephone contact at 60 days post-treatment.
The trial will investigate three dose regimens of microplasmin, all of which are within the range of doses previously evaluated in a Phase I trial in healthy volunteers; the planned sample size for the trial is approximately 40 patients.
The study will consist of 3 phases - the Baseline, In-hospital Phase and Follow up Phase. Baseline is from study entry through randomisation; the In-hospital phase is from treatment with study drug through hospital discharge or day 7, whichever occurs first. The follow up phase consists of visits to the hospital 30 days (+ 3 days) from the day of study drug administration. Hospital discharge is defined as the end of the discharge from the acute hospital setting. Discharge may be to home, to a rehabilitation setting or to a non-acute hospital setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Microplasmin |
| 2 | Experimental | Drug: Microplasmin |
| 3 | Experimental | Drug: Microplasmin |
| 4 | Placebo comparator | Drug: Microplasmin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute ischemic stroke with onset within 12 hours before randomization with baseline NIHSS > 6 and < 22
Key exclusion criteria (39 listed)
- General Exclusion Criteria
- Participation in another study with an investigational drug or device within the previous 30 days, prior participation in the present study, or planned participation in another trial within the time frame of the current trial
- Symptoms suggestive of subarachnoid hemorrhage, even if CT scan or MRI is negative for hemorrhage
- Women known to be pregnant, lactating, or having a positive or indeterminate pregnancy test
- Stroke Related Exclusion Criteria
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 |
|---|---|---|
| Microplasmin1mg/kg bolus of microplasmin solution followed by 1,2 or 3mg/kg infusion of mircroplasmin solution. | Drug | 1, 2, 3 |
| Microplasmin1mg/kg bolus of placebo solution followed by 1,2 or 3mg/kg infusion of placebo solution | Drug | 4 |
Primary outcome
Intracranial haemorrhage
Time frame: 24 hours and Day-7
Change from Baseline in NIHSS
Time frame: Day7 and Day-90
2 secondary outcomes
Barthel Index and modified Rankin scale
Time frame: Day-90
Markers of systemic lysis
Time frame: Baseline, end of treatment, 6, 12, 24, 72 and 96 hours
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 7 Nov 2014.
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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.
Vincent Thijs, MD PhD principal investigator
KU Leuven
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Microplasmin in people with Stroke, Acute, run by ThromboGenics at 16 sites in 3 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 1 inclusion and 39 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 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Austria, Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Intracranial haemorrhage (time frame: 24 hours and Day-7). The study lists 2 primary outcomes in all. 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 7 Nov 2014.