Safety and Efficacy Study in Acute Ischaemic Stroke

Phase 2

Completed

• Conditions: Stroke
• Interventions: Drug: V10153

• Registration Number: NCT00144014
• Lead Sponsor: Vernalis (R&D) Ltd

Brief Summary

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 Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Primary Completion: 2008-11
• Study Completion: 2009-03
• Status Verified: 2016-05
• Disposition First Submitted: 2016-05-04
• Disposition First Submitted QC: 2016-05-04
• Last Update Submitted: 2016-05-04
• Disposition First Posted: 2016-06-03
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V10153, 1.0 mg/kg	V10153	Single acute intravenous bolus dose
V10153, 2.5 mg/kg	V10153	Single acute intravenous bolus dose
V10153, 5.0 mg/kg	V10153	Single acute intravenous bolus dose
V10153, 7.5 mg/kg	V10153	Single acute intravenous bolus dose
V10153, 10 mg/kg	V10153	Single acute intravenous bolus dose

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

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

Trial Locations

Locations (28)

Stroke Centre, Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

UCLA Stroke Network; 🇺🇸 Los Angeles, California, United States

Neurology Medical Group of Diablo Valley; 🇺🇸 Walnut Creek, California, United States

Bethesda Memorial Hospital; 🇺🇸 Boynton Beach, Florida, United States

Bradenton Research Centre; 🇺🇸 Bradenton, Florida, United States

Ocala Neurodiagnostic Centre; 🇺🇸 Ocala, Florida, United States

Florida Hospital of Neuroscience Institute; 🇺🇸 Orlando, Florida, United States

Tallahassee Memorial Hospital; 🇺🇸 Tallahassee, Florida, United States

Florida Neurovascular Institue Stroke Center; 🇺🇸 Tampa, Florida, United States

Vascular Neurology, Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

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