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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
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
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Inclusion and exclusion criteria
Summary of Inclusion Criteria:
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
Primary purpose
Allocation
Interventional model
Masking
49 participants in 5 patient groups
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Data sourced from clinicaltrials.gov
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