Back to resultsA Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)
Primary Purpose
Arterial Ischemic Stroke
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Afamelanotide
Sponsored by
About this trial
This is an interventional treatment trial for Arterial Ischemic Stroke
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.
Sites / Locations
- The Alfred
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Afamelanotide
Arm Description
Outcomes
Primary Outcome Measures
Changes in Volume of Infarct
Secondary Outcome Measures
Changes of Neurological Function as Measured by the National Institutional Health Stroke Scale (NIHSS).
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)
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).
Full Information
NCT ID
NCT04962503
First Posted
June 23, 2021
Last Updated
March 16, 2023
Sponsor
Clinuvel Pharmaceuticals Limited
1. Study Identification
Unique Protocol Identification Number
NCT04962503
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
February 4, 2022 (Actual)
Study Completion Date
February 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinuvel Pharmaceuticals Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Afamelanotide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Afamelanotide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Volume of Infarct
Time Frame
From Day 0 to Day 3 and Day 0 to Day 9
Secondary Outcome Measure Information:
Title
Changes of Neurological Function as Measured by the National Institutional Health Stroke Scale (NIHSS).
Description
0: No stroke symptoms 1-15: Mild to Moderate stroke 16-20: Moderate to severe stroke 21- 42: Severe stroke
Time Frame
From baseline to Day 42
Title
Changes of Daily Activities as Measured by the Modified Rankin Scale (mRS)
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).
Time Frame
From baseline to Day 42
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The Alfred
City
Melbourne
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)
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