Methods

Description of the Clinical Trial

Phase 2b, randomized, double-blind, placebo-controlled, multicenter study.

Conducted in patients with rupture of an arterial aneurysm resulting in severe SAH treated according to standard of care.

Participants will undergo early CT or MRI imaging to confirm diagnosis and assess initial hemorrhage severity.

Randomization to EDV2209 or placebo in addition to standard of care (aneurysm securing, ICP control, nimodipine).

Follow-up imaging and biomarker assessments will evaluate tissue injury, perfusion, and inflammation over time.

At present Edvince aim for University Hospitals in Nordic countries to perform the phase 2b study.

Dosing

Route: Intrathecal administration (delivered directly into the cerebrospinal fluid).

Dose: 28.5μg/dose.

Schedule: Administered three times intrathecally – first dose within 8 hours after aneurysm rupture, followed by additional administrations at 12 and 24 hours.

Designed to maintain consistent exposure during the critical early injury window.

Primary Objective

To assess the effect of EDV2209 on functional outcome by GOSE at 3 months follow up placebo.

Secondary Objectives

Evaluate the effect of EDV2209 on neurological function (NIH Stroke Scale, cognitive measures).

Assess incidence and severity of delayed cerebral ischemia (DCI).

Determine relationship between imaging biomarkers (perfusion, infarct volume) and clinical recovery.

Characterize pharmacokinetics and safety profile across dose levels.