Clinical trial NCT01268683 (phase 1/phase 2, status: completed)
Conditions: ischemic stroke
ICD codes: I25.5, H47.013, H93.013, G45.9, H47.011, H47.012, H47.019
Drugs: rp-1127 (glyburide for injection)
SMILES: COC1=C(C=C(Cl)C=C1)C(=O)NCCC1=CC=C(C=C1)S(=O)(=O)NC(=O)NC1CCCCC1
Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of acute ischemic stroke in the MCA or MCA/ACA territory.

          -  Pre-morbid mRS 0 - 1.

          -  A baseline DWI lesion between 82 cm3 and 210 cm3 on MRI.

          -  Patients treated with IV rtPA should meet established criteria for IV rtPA
             administration in the 0-3 and 3-4.5 hr time periods, respectively.

          -  The time to the start of infusion of study compound must be ≤ 10 hr after time of
             symptom onset

          -  Age ≥18 years and ≤70 years.

          -  Provision of written informed consent by the patient or from a legally authorized
             representative according to institutional guidelines and national regulations.

        Exclusion Criteria:

          -  Evidence from imaging or pre-enrollment investigation of any diagnosis other than
             acute ischemic stroke likely to cause the presenting symptoms and signs.

          -  Commitment to decompressive craniectomy (DC) prior to enrollment, or follow-ing
             enrollment and prior to start of study compound.

          -  Treatment with IA rtPA or by mechanical means for clot disruption or with
             hypo-thermia.

          -  Patients unable to tolerate MRI scanning, e.g. those with pacemakers or automatic
             defibrillators.

          -  Pre-morbid mRS ≥ 2.

          -  Clinical signs of herniation, e.g. one or two dilated, fixed pupils; unconsciousness
             (i.e., ≥ 2 on item 1a on the NIHSS); loss of other brain stem reflexes attributable to
             herniation according to the investigator's judgment.

          -  CT or MRI evidence of hemorrhage or anteroseptal/pineal shift greater ≥2 mm prior to
             enrollment.

          -  Rapidly improving symptoms.

          -  Severe renal disorder from the patient's history (e.g. dialysis) or eGFR of < 30
             mL/min/1.73 m2.

          -  Severe liver disease or ALT, AST, or bilirubin >2 times normal.

          -  Blood glucose <55 mg/dL at enrollment or immediately prior to administration of
             RP-1127, or a clinically significant history of hypoglycemia.

          -  Diagnosis of decompensated heart failure (e.g. clinical diagnosis of pulmonary edema,
             chest x-ray consistent with heart failure, tachypnea > 20, etc.)

          -  Sulfonylurea treatment within 30 days.

          -  Known allergy to sulfa or specific allergy to sulfonylurea drugs.

          -  Known G6PD enzyme deficiency.

          -  Pregnancy or breast-feeding. Women must be either post-menopausal (judged by the
             investigator), permanently sterilized or, if of childbearing age, must have a negative
             test for pregnancy obtained before enrollment.

          -  Patients already enrolled in a non-observation-only stroke study, or with
             life-expectancy <3 months not related to current stroke, or those unlikely to be
             com-pliant with follow up.

          -  Patients who, in the opinion of the investigator, are not suitable for the study
             (rea-son to be documented).