Acute Ischemic Stroke
Conditions
Sponsors
Neurobiological Technologies Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sudden onset of an ischemia-related neurologic deficit involving the carotid, vertebrobasilar, or cerebral artery territories within 6 hours prior to screening, with symptoms persisting for = 30 minutes Subjects that awaken with stroke symptoms can be enrolled if they were without symptoms within the 6-hour window. 2. Clinical diagnosis of acute ischemic stroke based on a general physical examination, neurologic examination, and neuroimaging findings 3. Stroke symptoms occurring at a time that would allow initiation of study treatment within 6 hours of recognized onset Subjects will not be excluded based on CT evidence of the index ischemic stroke, but Investigators should be fully satisfied that they have determined the time of symptom onset if there is extensive change related to the index stroke. 4. No conditions other than stroke to which the subject's sudden clinical deterioration could have been attributed (e.g., pneumonia or systemic febrile infection), or that might interfere with the neurologic evaluation (e.g., demyelinating disease, superimposed encephalopathy, or multi-infarct dementia) 5. Age = 18 years 6. Men or women Women must not be pregnant or lactating, and women of childbearing potential must have a negative pregnancy test before receiving study drug. 7. Screening NIHSS score of = 5 8. mRS score of 0 or 1 prior to onset of index event 9. Written consent by the subject (or his/her representative if the subject is unable to sign personally) obtained and noted in the subject's chart Subjects who have signed an Informed Consent Form for any other acute study at the time of the index stroke, including studies involving the use of devices, may not be enrolled in this study. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Neuroimaging evidence of intracranial extravascular blood (e.g., cerebral hemorrhage, hemorrhagic infarction, subdural hematoma) or potentially progressive intracranial lesion (e.g., neoplasm or abscess) based on a CT scan of the head 2. Stroke known or strongly suspected to be caused by an arterial dissection 3. Unconscious or comatose state, that is, a score of > 2 on Item 1a of the NIHSS (level of consciousness) 4. Seizures at onset of the stroke 5. Prior stroke, ischemic or hemorrhagic, within the previous 6 weeks 6. Improvement in the clinical deficit to an NIHSS score of 185 mmHg or diastolic blood pressure of > 105 mmHg, or history of hypertension that is uncontrolled or accompanied by serious complications (e.g., hypertensive encephalopathy) 12. Last pretreatment systolic blood pressure of 3 × upper limit of normal [ULN]) • Renal failure (e.g., blood urea nitrogen [BUN] or creatinine > 2 × ULN) • Respiratory failure (e.g., respirator dependence) • Sepsis • Pericarditis, cardiogenic shock, or clinically significant congestive heart failure • Psychiatric disturbance (e.g., depression, schizophrenia, or organic brain syndrome) • Any other disease (e.g., advanced multiple sclerosis or dementia) likely to interfere with the neurologic assessment 21. Gastrointestinal or genitourinary bleeding within 30 days prior to screening 22. History of chronic alcohol abuse, alcohol abuse within 90 days prior to screening, or history of illicit drug use 23. Known or suspected vasculitis 24. Blood glucose of < 50 mg/dL 25. Prior treatment with ancrod 26. Use of another investigational drug within 30 days prior to stroke onset 27. Enrollment in another acute interventional s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of ancrod versus placebo, administered intravenously within 6 hours of stroke onset to subjects with an acute ischemic stroke, as determined by a responder analysis based on Modified Rankin Scale (mRS) score at Day 90.;Secondary Objective: The secondary objectives are as follows: • To evaluate the efficacy of ancrod versus placebo as determined by National Institutes of Health Stroke Scale (NIHSS) score at Day 90 • To evaluate the efficacy of ancrod versus placebo as determined by Barthel Index (BI) score at Day 90 • To evaluate fibrinogen levels associated with ancrod treatment • To evaluate the safety of ancrod treatment;Primary end point(s): reducing the incidences of disability at day 90 after start of treatment | — |
Countries
United Kingdom
Outcome results
None listed