Safety and Efficacy Study in Acute Ischaemic Stroke

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

Detailed Description
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Drug: V10153


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V10153, 1.0 mg/kg<br>Single acute intravenous bolus dose | Drug: V10153<br>* Single acute intravenous bolus dose up to 10 mg/kg<br>* Other names: Proposed INN: Troplasminogen alfa;|
| Experimental: V10153, 2.5 mg/kg<br>Single acute intravenous bolus dose | Drug: V10153<br>* Single acute intravenous bolus dose up to 10 mg/kg<br>* Other names: Proposed INN: Troplasminogen alfa;|
| Experimental: V10153, 5.0 mg/kg<br>Single acute intravenous bolus dose | Drug: V10153<br>* Single acute intravenous bolus dose up to 10 mg/kg<br>* Other names: Proposed INN: Troplasminogen alfa;|
| Experimental: V10153, 7.5 mg/kg<br>Single acute intravenous bolus dose | Drug: V10153<br>* Single acute intravenous bolus dose up to 10 mg/kg<br>* Other names: Proposed INN: Troplasminogen alfa;|
| Experimental: V10153, 10 mg/kg<br>Single acute intravenous bolus dose | Drug: V10153<br>* Single acute intravenous bolus dose up to 10 mg/kg<br>* Other names: Proposed INN: Troplasminogen alfa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | Ongoing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute, Ischaemic, Stroke