Safety and Efficacy Study in Acute Ischaemic Stroke

Stroke Clinical Trial

— VASST  

Official title:

A Phase II, Multi-centre, Two-part Study to Evaluate the Safety and Efficacy of Study Drug in Acute Ischaemic Stroke.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144014
• Other study ID #: V10153-2S-01
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2005
• Last updated: December 9, 2015
• Start date: August 2005
• Est. completion date: March 2009

Study information

• Verified date: December 2015
• Source: Vernalis (R&D) Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaDenmark: Danish Medicines AgencyHungary: National Institute of PharmacyCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• V10153
Single acute intravenous bolus dose up to 10 mg/kg

Locations

Country	Name	City	State
Canada	71 King Street West	Mississauga	Ontario
Canada	Hospital Charles LeMoyne	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Gordon & Leslie Diamond Health Care Centre	Vancouver	British Columbia
Canada	Centre for Stroke Research, Vancouver Island Health Research Centre	Victoria	British Columbia
United States	Bethesda Memorial Hospital	Boynton Beach	Florida
United States	Bradenton Research Centre	Bradenton	Florida
United States	Medical University South Carolina Hospitals and Clinics	Charleston	South Carolina
United States	Stroke Centre, Neurological Institute, Carolinas Medical Centre	Charlotte	North Carolina
United States	Erlanger Health System	Chattanooga	Tennessee
United States	Neurological Institute, The Methodist Hospital	Houston	Texas
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Sunrise Hospital and Medical Centre	Las Vegas	Nevada
United States	UCLA Stroke Network	Los Angeles	California
United States	Center for Advanced Medicine, Jewish Hospital	Louisville	Kentucky
United States	University of Louisville Hospital	Louisville	Kentucky
United States	Vascular Neurology, Loyola University Medical Center	Maywood	Illinois
United States	Ocala Neurodiagnostic Centre	Ocala	Florida
United States	Florida Hospital of Neuroscience Institute	Orlando	Florida
United States	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Washoe Stroke Center	Reno	Nevada
United States	Division of Neuro-Ophthalmology, Virginia Commonwealth University	Richmond	Virginia
United States	Stroke Centre, Mayo Clinic	Scottsdale	Arizona
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	Florida Neurovascular Institue Stroke Center	Tampa	Florida
United States	Neurology Medical Group of Diablo Valley	Walnut Creek	California
United States	Forsyth Medical Center	Winston Salem	North Carolina
United States	UMAS Memorial Medical Centre	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Vernalis (R&D) Ltd

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Ongoing	Yes
Secondary	To compare recanalisation rates across dose levels.		Ongoing	No
Secondary	To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index.		Post-study completion	No