A Phase IIa, Open Label, Proof of Concept Study to Evaluate the Safety of Aqueous Afamelanotide Solution in Patients with acute Arterial Ischaemic Stroke (AIS) who are ineligible for Intravenous Thrombolysis (IVT) or Endovascular Thrombectomy (EVT)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500919-40-01

Acronym

CUV803

Enrollment

Registered

2024-10-15

Start date

2023-03-10

Completion date

2024-11-19

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Ischaemic Stroke (AIS)

Brief summary

Safety of afamelanotide by monitoring and recording treatment-emergent AEs (TEAEs)

Detailed description

NIHSS scores compared to baseline, Reperfusion volume of the ischaemic core and the penumbral ischaemic zone (salvageable tissue), mRS scores compared to baseline and pre-stroke; Activities of Daily Living (ADL) compared to baseline and pre-stroke, MMSE scores compared to baseline

Interventions

DRUGPRENUMBRA

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety of afamelanotide by monitoring and recording treatment-emergent AEs (TEAEs)	—

Secondary

Measure	Time frame
NIHSS scores compared to baseline, Reperfusion volume of the ischaemic core and the penumbral ischaemic zone (salvageable tissue), mRS scores compared to baseline and pre-stroke; Activities of Daily Living (ADL) compared to baseline and pre-stroke, MMSE scores compared to baseline	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026