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

NCT ID: NCT04962503

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2022-02-04

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.

Conditions

Arterial Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Afamelanotide

Group Type: EXPERIMENTAL

Afamelanotide

Intervention Type: DRUG

Six adult patients with clots located in the higher segments of the brain and who are ineligible for alternative treatments will be enrolled in the study and evaluated for six weeks. The study will assess patients' brain injury with computed tomography (CT) scans and magnetic resonance imaging (MRI), as well as using recognised methods of clinical evaluation to measure changes in patients' neurological and cognitive function following treatment.

Interventions

Afamelanotide

Six adult patients with clots located in the higher segments of the brain and who are ineligible for alternative treatments will be enrolled in the study and evaluated for six weeks. The study will assess patients' brain injury with computed tomography (CT) scans and magnetic resonance imaging (MRI), as well as using recognised methods of clinical evaluation to measure changes in patients' neurological and cognitive function following treatment.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinuvel Pharmaceuticals Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Alfred

Melbourne, , Australia

Countries

Australia

References

Stanislaus V, Kam A, Murphy L, Wolgen P, Walker G, Bilbao P, Cloud GC. A feasibility and safety study of afamelanotide in acute stroke patients - an open label, proof of concept, phase iia clinical trial. BMC Neurol. 2023 Jul 26;23(1):281. doi: 10.1186/s12883-023-03338-9.

Reference Type: DERIVED

PMID: 37496004 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CUV801

Identifier Type: -

Identifier Source: org_study_id