Safety and Efficacy Study in Acute Ischaemic Stroke (VASST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vernalis (R&D) Ltd
ClinicalTrials.gov Identifier:
NCT00144014
First received: September 1, 2005
Last updated: May 4, 2016
Last verified: May 2016
  Purpose
A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke

Condition Intervention Phase
Stroke
Drug: V10153
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multi-centre, Two-part Study to Evaluate the Safety and Efficacy of Study Drug in Acute Ischaemic Stroke.

Further study details as provided by Vernalis (R&D) Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare recanalisation rates across dose levels. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index. [ Time Frame: Post-study completion ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: August 2005
Study Completion Date: March 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144014

  Show 28 Study Locations
Sponsors and Collaborators
Vernalis (R&D) Ltd
Investigators
Principal Investigator: Michael Hill Foothills Hosptial
  More Information

Responsible Party: Vernalis (R&D) Ltd
ClinicalTrials.gov Identifier: NCT00144014     History of Changes
Other Study ID Numbers: V10153-2S-01 
Study First Received: September 1, 2005
Last Updated: May 4, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Denmark: Danish Medicines Agency
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Vernalis (R&D) Ltd:
Acute
Ischaemic
Stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 25, 2016