Safety and Efficacy Study in Acute Ischaemic Stroke (VASST)

May 4, 2016 updated by: Vernalis (R&D) Ltd

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, J4V 2H1
        • Hospital Charles LeMoyne
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Gordon & Leslie Diamond Health Care Centre
      • Victoria, British Columbia, Canada, V8R 1J8
        • Centre for Stroke Research, Vancouver Island Health Research Centre
    • Ontario
      • Mississauga, Ontario, Canada, L5B 4A2
        • 71 King Street West
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0L4
        • Royal University Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85054
        • Stroke Centre, Mayo Clinic
    • California
      • Los Angeles, California, United States, 90024
        • UCLA Stroke Network
      • Walnut Creek, California, United States, 94598
        • Neurology Medical Group of Diablo Valley
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Bethesda Memorial Hospital
      • Bradenton, Florida, United States, 34205
        • Bradenton Research Centre
      • Ocala, Florida, United States, 34470
        • Ocala Neurodiagnostic Centre
      • Orlando, Florida, United States, 32804
        • Florida Hospital of Neuroscience Institute
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial Hospital
      • Tampa, Florida, United States, 33606
        • Florida Neurovascular Institue Stroke Center
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Vascular Neurology, Loyola University Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital
      • Louisville, Kentucky, United States, 40202
        • Center for Advanced Medicine, Jewish Hospital
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMAS Memorial Medical Centre
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Sunrise Hospital and Medical Centre
      • Reno, Nevada, United States, 89502
        • Washoe Stroke Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Stroke Centre, Neurological Institute, Carolinas Medical Centre
      • Winston Salem, North Carolina, United States, 27103
        • Forsyth Medical Center
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17602
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University South Carolina Hospitals and Clinics
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Erlanger Health System
    • Texas
      • Houston, Texas, United States, 77030
        • Neurological Institute, The Methodist Hospital
    • Virginia
      • Richmond, Virginia, United States, 23298-0599
        • Division of Neuro-Ophthalmology, Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Summary of Inclusion Criteria:

  1. Onset of new neurological signs of stroke within 3 to 9 hours of the time to initiation of treatment
  2. Aged 18 and above
  3. Provide consent
  4. 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.
  5. NIHSS score greater than 5 or less than or equal to 20.

Summary of Exclusion Criteria:

  1. Coma
  2. Stroke with unknown time of onset
  3. Minor stroke symptoms and sings (<6 points on the NIHSS) which are rapidly improving by the time of randomisation.
  4. Major stroke symptoms and signs (>20 on the NIHSS)
  5. History of stroke in previous 6 weeks
  6. History of brain tumours
  7. CT scan results in an ASPECT score of <5
  8. Haemorrhagic risk
  9. Abnormal laboratory values
  10. Positive urine pregnancy test, lactation or parturition within previous 30 days.
  11. Weight >135 kg
  12. Uncontrolled hypertension.
  13. Raised blood glucose
  14. History of or current serious illness

  15. Participation in another clinical trial within 4 weeks of drug administration

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: V10153, 1.0 mg/kg
Single acute intravenous bolus dose
Drug: V10153
Single acute intravenous bolus dose up to 10 mg/kg
Other Names:
  • Code Names: V10153, BB-10153
  • CAS Registry Number: 931101-84-7
  • Proposed INN: Troplasminogen alfa
Experimental: V10153, 2.5 mg/kg
Single acute intravenous bolus dose
Drug: V10153
Single acute intravenous bolus dose up to 10 mg/kg
Other Names:
  • Code Names: V10153, BB-10153
  • CAS Registry Number: 931101-84-7
  • Proposed INN: Troplasminogen alfa
Experimental: V10153, 5.0 mg/kg
Single acute intravenous bolus dose
Drug: V10153
Single acute intravenous bolus dose up to 10 mg/kg
Other Names:
  • Code Names: V10153, BB-10153
  • CAS Registry Number: 931101-84-7
  • Proposed INN: Troplasminogen alfa
Experimental: V10153, 7.5 mg/kg
Single acute intravenous bolus dose
Drug: V10153
Single acute intravenous bolus dose up to 10 mg/kg
Other Names:
  • Code Names: V10153, BB-10153
  • CAS Registry Number: 931101-84-7
  • Proposed INN: Troplasminogen alfa
Experimental: V10153, 10 mg/kg
Single acute intravenous bolus dose
Drug: V10153
Single acute intravenous bolus dose up to 10 mg/kg
Other Names:
  • Code Names: V10153, BB-10153
  • CAS Registry Number: 931101-84-7
  • Proposed INN: Troplasminogen alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Ongoing

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare recanalisation rates across dose levels.
Time Frame: Ongoing
Ongoing
To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index.
Time Frame: Post-study completion
Post-study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vernalis (R&D) Ltd

Investigators

  • Principal Investigator: Michael Hill, Foothills Hosptial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

May 4, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V10153-2S-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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