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Safety and Efficacy Study in Acute Ischaemic Stroke (VASST)

V

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)

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

Trial contacts and locations

28

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Data sourced from clinicaltrials.gov

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