Study design and patient population
hepatic or renal impairment, vessel occlusion, disability, allergic
This was a single centre, industry sponsored (CLINUVEL Pharmaceuticals), open label, non-randomised, prospective design, phase IIa trial of afamelanotide. The study was reviewed and approved by our Institutional Review Board (HREC/68,070/Alfred-2020). Eligible patients were older than 18 with limited functional disability at baseline (premorbid modified Rankin scale (mRS) < 4); had a diagnosis of first AIS; presented within 24 h of onset of symptoms; had a distal arterial vessel occlusion and relevant perfusion mismatch confirmed on imaging. Patients who underwent acute revascularisation therapies, pregnant, lactating, allergic to melanocortins, with severe hepatic or renal impairment or inability to undergo CT or MRI scans were excluded.