Phase IIa Aqueous Afamelanotide Solution Stroke Study
Key facts
- Where
- Bilbao és Valencia, SpanyolországSee the 2 sites
- Phase
- 2. fázis
Where in Spanyolország
- Hospital Universitario BasurtoBilbao, SpanyolországNo longer taking part
- Hospital Clinico Universitario de ValenciaValencia, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Clinuvel Europe Limited
- Trial code
- EU 2022-500919-40-01
- Record updated
- 2024. október 15.
- Original description
Evaluate the safety of afamelanotide in acute Arterial Ischaemic Stroke (AIS).Read full original descriptionShow less
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)
Evaluate the safety of afamelanotide in acute Arterial Ischaemic Stroke (AIS).
Inclusion: Male or female subjects with a diagnosis of first AIS; Six patients mild to moderate stroke severity and six patients moderate to severe stroke severity; At least three patients with an NIHSS score of 1-15 and at least three patients with NIHSS score greater than 15 will be recruited with perfusion abnormalities observed on Computed Tomography Perfusion (CTP) and the rest of the patients with no perfusion abnormalities but with clinically suspected AIS; Pre-stroke mRS <4; Aged 18- 85 years; Written informed consent obtained from patient and/or medical treatment decision maker prior to study-start (upon admission).
Exclusion: Administration of intravenous thrombolytic therapy in distal occlusion as etiology of AIS; Patients starting afamelanotide 24 hours or more from stroke; Known allergy or anaphylaxis to adrenocorticotropic hormone (ACTH) or melanocortins or any of the excipients listed in the Investigator’s Brochure; Any evidence of hepatic or renal impairment; Any other medical condition which may interfere with the study protocol; Not suitable for trial participation according to judgment of the Principal Investigator (PI); Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures, as described above; Intervention by endovascular thrombectomy (EVT); Female who is pregnant or lactating; Females of child-bearing potential not using highly effective contraceptive measures, for up to three months after the last injection; Unable to undergo MRI brain evaluation.