Clinical trial NCT04962503: A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)
Official title: A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) Due to Distal [M2 Segment and Beyond] Arterial Large Vessel Occlusion (LVO) or Perforator Occlusion and Who Are Ineligible for Intravenous Thrombolysis (IVT) or Endovascular Thrombectomy (EVT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arterial Ischemic Stroke
Lead sponsor: Clinuvel Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2021-07-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary study objective is to assess the safety of afamelanotide while the secondary objective is to assess whether the therapy affects the size of the penumbra, by increasing blood flow, restoring oxygen supply to the brain, and reducing the amount of cerebral oedema (fluid) which is seen as a result of the stroke. Positive findings would indicate that the drug is able to support brain tissue-at-risk and provide overall neuroprotection and benefit to stroke patients.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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
* Any evidence of hepatic (defined as three times standard range) or renal impairment (defined as estimated glomerular filtration rate (eGFR) \<50 mL/min/1.73 m²)
* Any other medical condition which may interfere with the study protocol
* Female who is pregnant (confirmed by positive serum beta human chorionic gonadotropin (β-HCG) pregnancy test prior to baseline) or lactating
* Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device) or a lifestyle excluding pregnancy
* Unable to undergo MRI brain evaluation
* Not suitable for trial participation according to judgment of the Principal Investigator (PI)
* Patients starting afamelanotide 24 hours or more from ictus.

Primary outcomes:
measure: Changes in Volume of Infarct
timeFrame: From Day 0 to Day 3 and Day 0 to Day 9
Secondary outcomes:
measure: Changes of Neurological Function as Measured by the National Institutional Health Stroke Scale (NIHSS).
timeFrame: From baseline to Day 42
measure: Changes of Daily Activities as Measured by the Modified Rankin Scale (mRS)
timeFrame: From baseline to Day 42
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred
Study officials:
References: