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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT04962503 (opens ClinicalTrials.gov in a new tab)Other idCUV801
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
6 participants (actual)
Sponsor
Clinuvel Pharmaceuticals Limited · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Australia

Start
3 Jun 2021
Primary completion
4 Feb 2022
Completion
4 Feb 2022
First posted
15 Jul 2021
Last update posted
11 Apr 2023
Conditions
Arterial Ischemic Stroke

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 2

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

    NCT04962503

    3 Jun 2021 to 4 Feb 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • AfamelanotideDrug

Arms1

  • Experimental

    Afamelanotide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Changes in Volume of Infarct

    Time frame · From Day 0 to Day 3 and Day 0 to Day 9

Secondary outcomes(2)

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

    Time frame · From baseline to Day 42

    Registry description

    0: No stroke symptoms 1-15: Mild to Moderate stroke 16-20: Moderate to severe stroke 21- 42: Severe stroke

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

    Time frame · From baseline to Day 42

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· From Day 0 to Day 3 and Day 0 to Day 9

Changes in Volume of Infarct

GroupValue (mL)
SCENESSE® (Afamelanotide 16mg)9.97
Secondary and other outcome results(2)
Secondary outcomeMedian· From baseline to Day 42

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

GroupValue (Score on a scale)
SCENESSE® (Afamelanotide 16mg)-4.5
Secondary outcomeCount of participants· From baseline to Day 42

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

GroupValue (Participants)
SCENESSE® (Afamelanotide 16mg)4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SCENESSE® (Afamelanotide 16mg)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.1 / 61 / 65 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2023

4 results

A feasibility and safety study of afamelanotide in acute stroke patients - an open label, proof of concept, phase iia clinical trial.

Stanislaus et al. 2023BMC neurologycited by 3

PMID 37496004PMC10373257DOI 10.1186/s12883-023-03338-9PUB-37496004

CC BY4 results
Download PDFSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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