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)
interventional
N/A
1 country
2
Evaluate the safety of afamelanotide in acute Arterial Ischaemic Stroke (AIS).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 9, 2024
Actual (reported)Safety of afamelanotide by monitoring and recording treatment-emergent AEs (TEAEs)
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
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
PRENUMBRA
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
PRENUMBRA
Named ingredient: afamelanotide
View registry recordHospital Clinico Universitario De Valencia
Valencia, 46010, Spain
Hospital Universitario Basurto
Bilbao, 48013, Spain
Head of Clinical Operations
First Submitted
October 9, 2024
Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
Contact the study team to confirm eligibility.