A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)

Phase 2

Completed

• Conditions: Arterial Ischemic Stroke
• Interventions: Drug: Afamelanotide

• Registration Number: NCT04962503
• Lead Sponsor: Clinuvel Pharmaceuticals Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-03
• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-07-10
• Study First Posted: 2021-07-15
• Primary Completion: 2022-02-04
• Study Completion: 2022-02-04
• Results First Submitted: 2023-02-03
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-16
• Last Update Submitted: 2023-03-16
• Results First Posted: 2023-04-11
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Afamelanotide	Afamelanotide	-

Primary Outcome Measures

Name	Time	Method
Changes in Volume of Infarct	From Day 0 to Day 3 and Day 0 to Day 9

Secondary Outcome Measures

Name	Time	Method
Changes of Neurological Function as Measured by the National Institutional Health Stroke Scale (NIHSS).	From baseline to Day 42	0: No stroke symptoms 1-15: Mild to Moderate stroke 16-20: Moderate to severe stroke 21- 42: Severe stroke
Changes of Daily Activities as Measured by the Modified Rankin Scale (mRS)	From baseline to Day 42	The mRS indicates the degree of disability or dependence in the daily activities of patients who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms (0) to death (+6).

Trial Locations

Locations (1)

The Alfred; 🇦🇺 Melbourne, Australia