Safety and Efficacy Study in Acute Ischaemic Stroke (VASST)

Vernalis Therapeutics

Status and phase: Completed; Phase 2

Conditions: Stroke

Treatments: Drug: V10153

Study type: Interventional

Funder types: Industry

Identifiers

NCT00144014

V10153-2S-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 5 patient groups

V10153, 1.0 mg/kg

Experimental group

Description:

Single acute intravenous bolus dose

Treatment:

Drug: V10153

V10153, 2.5 mg/kg

Experimental group

Description:

Single acute intravenous bolus dose

Treatment:

Drug: V10153

V10153, 5.0 mg/kg

Experimental group

Description:

Single acute intravenous bolus dose

Treatment:

Drug: V10153

V10153, 7.5 mg/kg

Experimental group

Description:

Single acute intravenous bolus dose

Treatment:

Drug: V10153

V10153, 10 mg/kg

Experimental group

Description:

Single acute intravenous bolus dose

Treatment:

Drug: V10153