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Clinical Trials/NCT00144014
NCT00144014CompletedPhase 2

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

Vernalis (R&D) Ltd28 sites in 2 countries49 target enrollmentStarted: August 2005Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
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

Experimental

Single acute intravenous bolus dose

Intervention: V10153 (Drug)

V10153, 2.5 mg/kg

Experimental

Single acute intravenous bolus dose

Intervention: V10153 (Drug)

V10153, 5.0 mg/kg

Experimental

Single acute intravenous bolus dose

Intervention: V10153 (Drug)

V10153, 7.5 mg/kg

Experimental

Single acute intravenous bolus dose

Intervention: V10153 (Drug)

V10153, 10 mg/kg

Experimental

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (28)

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