StrokePhase 2VASSTNCT00144014
Safety and Efficacy Study in Acute Ischaemic Stroke
A Phase 2 study testing V10153 in people with Stroke, run by Vernalis (R&D) Ltd at 28 sites in 2 countries.
Trial summary
A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- V10153
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Aug 2005to Mar 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Summary of Inclusion Criteria:
- Onset of new neurological signs of stroke within 3 to 9 hours of the time to initiation of treatment
- Aged 18 and above
- Provide consent
- Cerebral CT scan to show findings of early ischaemic changes consistent with the clinical diagnosis and an ASPECT score of between 5 and 10 inclusive.
- NIHSS score greater than 5 or less than or equal to 20.
Summary of Exclusion Criteria:
- Coma
- Stroke with unknown time of onset
- Minor stroke symptoms and sings (<6 points on the NIHSS) which are rapidly improving by the time of randomisation.
- Major stroke symptoms and signs (>20 on the NIHSS)
- History of stroke in previous 6 weeks
- History of brain tumours
- CT scan results in an ASPECT score of <5
- Haemorrhagic risk
- Abnormal laboratory values
- Positive urine pregnancy test, lactation or parturition within previous 30 days.
- Weight >135 kg
- Uncontrolled hypertension.
- Raised blood glucose
- History of or current serious illness
- Participation in another clinical trial within 4 weeks of drug administration -
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States23 sites
Bethesda Memorial Hospital
Boynton Beach, Florida, 33435
Bradenton Research Centre
Bradenton, Florida, 34205
Medical University South Carolina Hospitals and Clinics
Charleston, South Carolina, 29425
Stroke Centre, Neurological Institute, Carolinas Medical Centre
Charlotte, North Carolina, 28203
Erlanger Health System
Chattanooga, Tennessee, 37404
Neurological Institute, The Methodist Hospital
Houston, Texas, 77030
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Sunrise Hospital and Medical Centre
Las Vegas, Nevada, 89109
UCLA Stroke Network
Los Angeles, California, 90024
Center for Advanced Medicine, Jewish Hospital
Louisville, Kentucky, 40202
University of Louisville Hospital
Louisville, Kentucky, 40202
Vascular Neurology, Loyola University Medical Center
Maywood, Illinois, 60153
Ocala Neurodiagnostic Centre
Ocala, Florida, 34470
Florida Hospital of Neuroscience Institute
Orlando, Florida, 32804
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Washoe Stroke Center
Reno, Nevada, 89502
Division of Neuro-Ophthalmology, Virginia Commonwealth University
Richmond, Virginia, 23298-0599
Stroke Centre, Mayo Clinic
Scottsdale, Arizona, 85054
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
Florida Neurovascular Institue Stroke Center
Tampa, Florida, 33606
Neurology Medical Group of Diablo Valley
Walnut Creek, California, 94598
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
UMAS Memorial Medical Centre
Worcester, Massachusetts, 01655
Canada5 sites
71 King Street West
Mississauga, Ontario, L5B 4A2
Hospital Charles LeMoyne
Québec, J4V 2H1
Royal University Hospital
Saskatoon, Saskatchewan, S7K 0L4
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9
Centre for Stroke Research, Vancouver Island Health Research Centre
Victoria, British Columbia, V8R 1J8
About this study
Official title: A Phase II, Multi-centre, Two-part Study to Evaluate the Safety and Efficacy of Study Drug in Acute Ischaemic Stroke.
A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke
Read the detailed description
An open label, dose escalation study where patients with acute ischaemic stroke will receive a single intravenous dose of study drug. There will be five dose levels with groups of 10 patients in each. Escalation to higher doses will occur following review of safety data from the previous dose.
- Conditions
- Stroke
- Being tested
- V10153
- Keywords
- Acute, Ischaemic, Stroke
- Medical subject headings
- Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V10153Drug
Also called Code Names: V10153, BB-10153, CAS Registry Number: 931101-84-7, Proposed INN: Troplasminogen alfa
Single acute intravenous bolus dose up to 10 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| V10153, 1.0 mg/kg | Experimental | Single acute intravenous bolus dose Receives: Drug: V10153 |
| V10153, 2.5 mg/kg | Experimental | Single acute intravenous bolus dose Receives: Drug: V10153 |
| V10153, 5.0 mg/kg | Experimental | Single acute intravenous bolus dose Receives: Drug: V10153 |
| V10153, 7.5 mg/kg | Experimental | Single acute intravenous bolus dose Receives: Drug: V10153 |
| V10153, 10 mg/kg | Experimental | Single acute intravenous bolus dose Receives: Drug: V10153 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the safety of five dose levels (1.0, 2.5, 5, 7.5 and 10 mg/kg)of V10153 in patients with acute ischaemic stroke.
Measured: Ongoing
Secondary outcomes (2)
To compare recanalisation rates across dose levels.
Measured: Ongoing
To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index.
Measured: Post-study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionNov 2008
- Study completionMar 2009
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vernalis (R&D) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Hill, Principal investigator, Foothills Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144014
- Sponsor's protocol ID
- V10153-2S-01
- Acronym
- VASST
- Status last verified
- May 2016
- First submitted
- 1 Sep 2005
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-centre, Two-part Study to Evaluate the Safety and Efficacy of Study Drug in Acute Ischaemic Stroke.
- ClinicalTrials.gov ID
- NCT00144014
- Acronym / sponsor ID
- VASST / V10153-2S-01
- Conditions
- Stroke
- Keywords
- Acute, Ischaemic, Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Vernalis (R&D) LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Sep 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.
A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke
Detailed description
An open label, dose escalation study where patients with acute ischaemic stroke will receive a single intravenous dose of study drug. There will be five dose levels with groups of 10 patients in each. Escalation to higher doses will occur following review of safety data from the previous dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| V10153, 1.0 mg/kg | Experimental | Drug: V10153Single acute intravenous bolus dose |
| V10153, 2.5 mg/kg | Experimental | Drug: V10153Single acute intravenous bolus dose |
| V10153, 5.0 mg/kg | Experimental | Drug: V10153Single acute intravenous bolus dose |
| V10153, 7.5 mg/kg | Experimental | Drug: V10153Single acute intravenous bolus dose |
| V10153, 10 mg/kg | Experimental | Drug: V10153Single acute intravenous bolus dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| V10153Also: Code Names: V10153, BB-10153, CAS Registry Number: 931101-84-7, Proposed INN: Troplasminogen alfaSingle acute intravenous bolus dose up to 10 mg/kg | Drug | V10153, 1.0 mg/kg, V10153, 10 mg/kg, V10153, 2.5 mg/kg, V10153, 5.0 mg/kg, V10153, 7.5 mg/kg |
Primary outcome
To establish the safety of five dose levels (1.0, 2.5, 5, 7.5 and 10 mg/kg)of V10153 in patients with acute ischaemic stroke.
Time frame: Ongoing
2 secondary outcomes
To compare recanalisation rates across dose levels.
Time frame: Ongoing
To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index.
Time frame: Post-study completion
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 3 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Michael Hill principal investigator
Foothills Hosptial
28 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 V10153 in people with Stroke, run by Vernalis (R&D) Ltd at 28 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?
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 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Canada. 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 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?
To establish the safety of five dose levels (1.0, 2.5, 5, 7.5 and 10 mg/kg)of V10153 in patients with acute ischaemic stroke. (time frame: Ongoing). 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 3 Jun 2016.