Neurology · Phase 2
Afamelanotide: early stroke feasibility
What was tested?
Open-label afamelanotide in six patients with acute ischemic stroke who could not receive the specified revascularization treatments. ↗
Registered primary question: Change in infarct volume from day 0 to days 3 and 9. ↗
What the reviewed report found
Journal year 2023 · Article summary reviewed 2026-09-15
The surviving patients showed neurological improvement. One patient died after a recurrent stroke, which investigators assessed as unrelated to the study drug.↗
Keep in context: The registry lists imaging as the primary outcome; the article emphasizes feasibility and safety. Six uncontrolled observations cannot establish treatment efficacy or safety. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Outcome emphasis differs between sources
The article methods identify adverse-event monitoring through day 42 as the primary outcome and imaging as secondary. The retrieved registry lists infarct-volume change as primary. This is a source discrepancy, not proof of why the designation changed. Full text ↗ · Indexed abstract ↗
Sections: Outcome measures.
What uncontrolled recovery can show
The study was open label and nonrandomized. The authors acknowledge the small sample and that neurological improvement could reflect natural recovery. A larger randomized comparison is needed to attribute recovery to treatment. Full text ↗ · Indexed abstract ↗
Sections: Study design and patient population; Strengths and limitations.
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 6 · reported actual
- Registry status
- Completed
- Allocation and masking
- Na · Open label
- Design
- Single group
- Eligible ages
- 18 Years to 85 Years
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2023-04-11; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Acute stroke: early feasibility study
- Design in the report
- An open-label Phase 2a study assessed safety and exploratory recovery measures without a control group.↗
- Participants in the report
- Six patients with acute ischemic stroke who were ineligible for revascularization therapies were enrolled.↗
- Limitations
- Six uncontrolled observations cannot distinguish drug effects from natural recovery or establish safety. The authors called for randomized studies.↗
This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) ↗
Protocol identifier: CUV801. Sponsor: Clinuvel Pharmaceuticals Limited.
Retrieved 2026-09-20; SHA-256 6c500272cfb0bd764cfb726e54c94507f52ef42e6b6eb5005d4c253f06e7aa92.
PMID 37496004
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. EFetch batch XML; locate MedlineCitation/PMID 37496004. SHA-256 f2177628b98083064df17512c3dd229b760887c00cc64c4cfa4fc4e49523b12a.
Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 731b17aa519b1df6a26947c5ca31db8b851762d0fecfa77c45625f3b1c6bf266.
Selected full text: PMC10373257
Retrieved 2026-09-20; SHA-256 a007a591d4823f9616594f8dd8d1d57bf73ca8fc1769c47af482c6167dc795ce. Section identifiers and hashes are included in the cited study data.