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

Condition	Intervention	Phase
Stroke	Drug: Study drug	Phase II

Further Study Details: 

Primary Outcomes: Safety will be determined through clinical assessment (intracranial haemorrhage (ICH), major systemic bleeding, other serious adverse events).
Secondary Outcomes: Recanalisaiton reates from CT angiograms will be compared across doses.; Clinical outcome according to NIHSS, modified Rankin Scale and Barthel Index.; Safety will be determined by CT scan for evidence of ICH, adverse events, laboratory variables, vital signs, ECG
Expected Total Enrollment:  40

An open label, dose escalation study where patients with acute ischaemic stroke will receive a single intravenouse dose of study drug. There will be four dose levels with groups of 10 patients in each. Escalation to higher doses will occur following review of safety data from the previous dose.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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 18-80
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 between 6-20

   -

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. Abonormal laboratory values
10. Positive urine pregnancy test, lactation or parturition within previous 30 days.
11. Weight >120 kg
12. Uncontrolled hypertension.
13. Raised blood glucose
14. History of or current serious illness

15. Participation in another clinical trial witin 4 weeks of drug administration

    -

Please refer to this study by ClinicalTrials.gov identifier  NCT00144014

Michael Hill, MD      403 944 8065 

Arizona
      Stroke Centre, Scottsdale,  Arizona,  85259,  United States; Not yet recruiting
Canada
      Hospital Charles LeMoyne, Quebec,  J4V 2J2,  Canada; Not yet recruiting
Canada, Alberta
      Foothills Hospital, Calgary,  Alberta,  T2N 2T9,  Canada; Recruiting
      Walter Mackenzie Health Sciences Centre, Edmonton,  Alberta,  T6G 2B7,  Canada; Recruiting
Canada, British Columbia
      The Fairmont Medical Building, Vancouver,  British Columbia,  V5Z 1H7,  Canada; Not yet recruiting
      Centre for Stroke Research, Victoria,  British Columbia,  V8R 1J8,  Canada; Not yet recruiting
Canada, Ontario
      71 King Street West, Mississauga,  Ontario,  L5B 4A2,  Canada; Not yet recruiting
Canada, Saskatchewan
      Royal University Hospital, Saskatoon,  Saskatchewan,  S7K 0L4,  Canada; Not yet recruiting

Study chairs or principal investigators

Michael Hill,  Principal Investigator,  Foothills Hosptial   

Study ID Numbers:  V10153-2S-01
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00144014
Health Authority: United States: Food and Drug Administration; Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-06