To determine the lowest doses required to produce blood levels of caffeine and ethanol (caffeinol) in the target range (8-10 ug/mL and 30-50 mg/dL) and to determine the safety and tolerability of intravenous caffeinol in patients with acute ischemic stroke.
FDA-approved, open-label, single-arm, dose-escalation pilot study.
Prior to enrollment, patients underwent CT scanning, and had baseline blood levels of caffeine and ethanol drawn. Eligible patients were divided into three dose-groups of 10 participants each. The first was be infused with caffeine 6 mg/kg and ethanol 0.2 gm/kg, the second received 8 mg/kg caffeine and 0.4 mg/kg ethanol, and the third received 10 mg/kg caffeine and 0.6 mg ethanol within 6 hours of stroke. At the end of infusion, patients' caffeine and ethanol blood levels were measured again. Safety was monitored independently, and entry into a dose-group was to be stopped if 2 consecutive patients had caffeine or ethanol blood levels outside the target range, or demonstrated side effects from the caffeinol. All patients were evaluated at 24 hours and at 3 months post-treatment.
|Type||Measure||Time Frame||Safety Issue|
|Primary||NIHSS and modified Rankin scale (MRS) scores at 24 hours and 3 months.|
|Secondary||End-infusion caffeine and ethanol blood levels, evidence of caffeine- or ethanol-related side effects|