A Phase II, Multi-centre, Two-part Study to Evaluate the Safety and Efficacy of Study Drug in Acute Ischaemic Stroke.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Vernalis (R&D) Ltd
- Enrollment
- 49
- Locations
- 28
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- •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
Arms & Interventions
V10153, 1.0 mg/kg
Single acute intravenous bolus dose
Intervention: V10153 (Drug)
V10153, 2.5 mg/kg
Single acute intravenous bolus dose
Intervention: V10153 (Drug)
V10153, 5.0 mg/kg
Single acute intravenous bolus dose
Intervention: V10153 (Drug)
V10153, 7.5 mg/kg
Single acute intravenous bolus dose
Intervention: V10153 (Drug)
V10153, 10 mg/kg
Single acute intravenous bolus dose
Intervention: V10153 (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)