Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Phase-II Trial: AdrenoMedullin for Ischemic Stroke...

Area of Science:

• Vascular biology and neurology
• Pharmacological interventions for stroke
• Inflammatory and angiogenic pathways

Background:

• Adrenomedullin (AM) possesses anti-inflammatory and angiogenic properties, showing promise in preclinical models of ischemic stroke.
• Previous studies include a phase I trial in healthy volunteers and two completed phase II trials for inflammatory bowel diseases.
• The AdrenoMedullin For Ischemic Stroke (AMFIS) study investigates AM's potential in acute ischemic stroke patients.

Purpose of the Study:

• To evaluate the safety and efficacy of Adrenomedullin (AM) in patients experiencing acute ischemic stroke.
• To determine the optimal dosage and treatment regimen for AM in stroke patients.
• To assess the impact of AM on neurological deficit and functional outcomes post-stroke.

Main Methods:

• An investigator-initiated, randomized, double-blind, phase-II clinical trial (AMFIS study).
• Patients with non-cardioembolic ischemic stroke receive either AM or placebo within 24 hours of onset.
• Two treatment cohorts: Cohort A (20 patients, 30 μg/kg total AM) and Cohort B (20 patients, 56 μg/kg total AM), each with a placebo group (10 patients).

Main Results:

• Primary outcome: evaluation of serious adverse events related to protocol treatment.
• Secondary outcome: analysis of all adverse events.
• Efficacy endpoints include changes in National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) scores compared to placebo.

Conclusions:

• Adrenomedullin (AM) is anticipated to be a safe and effective therapeutic agent for ischemic stroke.
• The AMFIS study will provide crucial data on AM's clinical utility in stroke management.
• Further research may establish AM as a novel treatment option for improving stroke outcomes.