StrokePhase 2MITI-IANCT00123266
Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion
A Phase 2 study testing Microplasmin in people with Stroke, run by ThromboGenics at 7 sites in 2 countries.
Trial summary
The purpose of the trial is to evaluate the safety of microplasmin as well as its ability to open blocked arteries to the brain in patients with acute stroke when given into the artery at the site of the blockage. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Microplasmin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2006to Aug 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with angiographically documented vertebrobasilar artery occlusion
- Initiation of study drug treatment within 24 hours of the onset of neurological symptoms
- Age 18-75 (inclusive).
Who cannot join
- Patients with coma > 6 hrs duration and complete loss of brain stem reflexes (corneal reflex, gag reflex, VOR, pupil reflexes) as measured at the last assessment before sedation/intubation
- Rapidly improving neurologic signs at any time before initiation of study drug administration.
- Known contrast agent-sensitivity
- 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 IV therapy.
- History of stroke within the previous 6 weeks.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Germany6 sites
Universitätsklinikum Erlangen
Erlangen, D-91054
Universitatsklinikum Freiburg
Freiburg im Breisgau, D-79106
Universitätsklinikum des Saarlandes
Homburg/Saar, 66421
UKSH Campus Kiel
Kiel, 24105
Ludwig-Maximilians-University Hospital
Munich
HSK Dr. Horst Schmidt Hospital
Wiesbaden, 65199
About this study
Official title: An Open-label, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion
The purpose of the trial is to evaluate the safety of microplasmin as well as its ability to open blocked arteries to the brain in patients with acute stroke when given into the artery at the site of the blockage.
Read the detailed description
Patients with angiographically documented acute intracranial vertebrobasilar artery occlusion presenting within 24 hours of neurological symptom onset will be enrolled into this open-label trial. During study drug administration, angiograms will be repeated at regular intervals to determine degree of clot lysis.
- Conditions
- Stroke
- Being tested
- Microplasmin
- Keywords
- stroke, vertebrobasilar, basilar, Acute vertebrobasilar artery occlusion
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroplasminDrug
2 mg/kg, IA over 75 mins
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: Microplasmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recanalization rate
Measured: Day-7, Day-30 and Day-90
Secondary outcomes (1)
Clinical assessment
Measured: Day-7, Day-30 and Day-90
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 startDec 2006
- Primary completionJul 2007
- Study completionAug 2008
Why it stopped: Sponsor's decision not to pursue development of uPLi for vascular conditions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerhard Hamann, Prof. Dr, Principal investigator, HSK Dr. Horst Schmidt Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123266
- Sponsor's protocol ID
- TG-M-003
- Acronym
- MITI-IA
- Status last verified
- Apr 2014
- First submitted
- 21 Jul 2005
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion
- ClinicalTrials.gov ID
- NCT00123266
- Acronym / sponsor ID
- MITI-IA / TG-M-003
- Conditions
- Stroke
- Keywords
- stroke, vertebrobasilar, basilar, Acute vertebrobasilar artery occlusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision not to pursue development of uPLi for vascular conditions.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Aug 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 purpose of the trial is to evaluate the safety of microplasmin as well as its ability to open blocked arteries to the brain in patients with acute stroke when given into the artery at the site of the blockage.
Detailed description
Patients with angiographically documented acute intracranial vertebrobasilar artery occlusion presenting within 24 hours of neurological symptom onset will be enrolled into this open-label trial. During study drug administration, angiograms will be repeated at regular intervals to determine degree of clot lysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Microplasmin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with angiographically documented vertebrobasilar artery occlusion
- Initiation of study drug treatment within 24 hours of the onset of neurological symptoms
- Age 18-75 (inclusive).
Key exclusion criteria (5 listed)
- Patients with coma > 6 hrs duration and complete loss of brain stem reflexes (corneal reflex, gag reflex, VOR, pupil reflexes) as measured at the last assessment before sedation/intubation
- Rapidly improving neurologic signs at any time before initiation of study drug administration.
- Known contrast agent-sensitivity
- 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 IV therapy.
- History of stroke within the previous 6 weeks.
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 |
|---|---|---|
| Microplasmin2 mg/kg, IA over 75 mins | Drug | Active |
Primary outcome
Recanalization rate
Time frame: Day-7, Day-30 and Day-90
1 secondary outcome
Clinical assessment
Time frame: Day-7, Day-30 and Day-90
Results and safety
The study was stopped early (reason given: Sponsor's decision not to pursue development of uPLi for vascular conditions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 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.
Gerhard Hamann, Prof. Dr principal investigator
HSK Dr. Horst Schmidt Hospital
7 sites in 2 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, run by ThromboGenics at 7 sites in 2 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Netherlands. 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. 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 was stopped early (reason given: Sponsor's decision not to pursue development of uPLi for vascular conditions.). Results are not available in the source record.
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?
Recanalization rate (time frame: Day-7, Day-30 and Day-90). 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 Apr 2014.