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A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)
Plain-language guide to NCT04962503: phase 2 interventional trial of Melanotan I, 6 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04962503
- Phase
- phase 2
- Status
- completed
- Start
- 2021-06-03
- Completion (planned or actual)
- 2022-02-04
- Participants
- 6 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Arterial Ischemic Stroke
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Melanotan I.
It had 1 arm (groups): Afamelanotide (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 6 actual participants took part.
It was open to people of any sex aged from 18 years up to 85 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female subjects with a diagnosis of first AIS due to distal \[M2 segment and beyond\] occlusion or perforator occlusion. Perfusion abnormalities observed on Computed Tomography Perfusion (CTP). Mild to moderate stroke severity. Pre-stroke mRS \<4. Written informed consent obtained from patient and/or medical treatment decision maker prior to study-start (upon admission).
The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: administration of intravenous thrombolytic therapy in distal occlusion as etiology of ais; intervention by endovascular thrombectomy (evt); known allergy or anaphylaxis to adrenocorticotropic hormone (acth) or melanocortins or any of the excipients listed in the investigator's brochure.
How the Study Was Run
It was run as a single-group and open-label study.
Being open-label, the Melanotan I study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2021-06-03 with completion listed for 2022-02-04.
It ran at 1 site in Australia.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Changes in Volume of Infarct (time frame: From Day 0 to Day 3 and Day 0 to Day 9).
It also tracked 2 secondary outcomes, for example Changes of Neurological Function as Measured by the National Institutional Health Stroke Scale (NIHSS) and Changes of Daily Activities as Measured by the Modified Rankin Scale (mRS).
What This Means in Plain Language
Put simply, this is a phase 2 trial of Melanotan I in 6 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Melanotan I compound page, all human trials.
Our Notes on the Compound
Melanotan I: A synthetic melanotropin (α-MSH analog), afamelanotide, studied for pigmentation; the approved product is an implant.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.