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

NCT04962503 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CUV801
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes in Volume of Infarct

  From Day 0 to Day 3 and Day 0 to Day 9

Secondary Outcomes (2)

• Changes of Neurological Function as Measured by the National Institutional Health Stroke Scale (NIHSS).

  From baseline to Day 42

• Changes of Daily Activities as Measured by the Modified Rankin Scale (mRS)

  From baseline to Day 42

Study Arms (1)

Afamelanotide

EXPERIMENTAL

Drug: Afamelanotide

Interventions

Afamelanotide 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.

Afamelanotide

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinuvel Pharmaceuticals Limited: lead

Study Sites (1)

The Alfred

Melbourne, Australia

Location

Related Publications (1)

• 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.

  PMID: 37496004 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

afamelanotide

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clinical Operations Manager
• Organization: CLINUVEL PHARMACEUTICALS LIMITED

mail@clinuvel.com

Tel: +61 3 9660 4900

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 15, 2021
• Study Start: June 3, 2021
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: April 11, 2023
• Results First Posted: April 11, 2023

Record last verified: 2023-03

Locations

AU (1)