BridgeMD
Phase IIa Aqueous Afamelanotide Solution Stroke Study
EU CTIS ID: 2022-500919-40-01
What this study is testing
Evaluate the safety of afamelanotide in acute Arterial Ischaemic Stroke (AIS).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- Administration of intravenous thrombolytic therapy in distal occlusion as etiology of AIS
- 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
- Patients starting afamelanotide 24 hours or more from stroke.
- 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
See the full eligibility criteria
- 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)
- Administration of intravenous thrombolytic therapy in distal occlusion as etiology of AIS
- 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
- Patients starting afamelanotide 24 hours or more from stroke.
- 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
- Any evidence of hepatic or renal impairment
- Any other medical condition which may interfere with the study protocol
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.