Trial Outcomes & Findings for A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) (NCT NCT04962503)
NCT ID: NCT04962503
Last Updated: 2023-04-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
From Day 0 to Day 3 and Day 0 to Day 9
Results posted on
2023-04-11
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)
Baseline characteristics by cohort
| Measure |
SCENESSE® (Afamelanotide 16mg)
n=6 Participants
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.
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|---|---|
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Age, Continuous
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76.0 years
n=5 Participants
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Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · Caucasian
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5 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · Unknown or Not Reported
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From Day 0 to Day 3 and Day 0 to Day 9Outcome measures
| Measure |
SCENESSE® (Afamelanotide 16mg)
n=5 Participants
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.
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|---|---|
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Changes in Volume of Infarct
Median change from baseline to Day 3
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9.97 mL
Interval 1.71 to 59.6
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Changes in Volume of Infarct
Median change from baseline to Day 9
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4.06 mL
Interval 1.41 to 57.6
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SECONDARY outcome
Timeframe: From baseline to Day 420: No stroke symptoms 1-15: Mild to Moderate stroke 16-20: Moderate to severe stroke 21- 42: Severe stroke
Outcome measures
| Measure |
SCENESSE® (Afamelanotide 16mg)
n=6 Participants
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.
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|---|---|
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Changes of Neurological Function as Measured by the National Institutional Health Stroke Scale (NIHSS).
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-4.5 Score on a scale
Interval -8.0 to 41.0
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SECONDARY outcome
Timeframe: From baseline to Day 42The 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).
Outcome measures
| Measure |
SCENESSE® (Afamelanotide 16mg)
n=6 Participants
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.
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|---|---|
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Changes of Daily Activities as Measured by the Modified Rankin Scale (mRS)
Day 42 score 3
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3 Participants
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Changes of Daily Activities as Measured by the Modified Rankin Scale (mRS)
Pre-stroke score 0
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4 Participants
|
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Changes of Daily Activities as Measured by the Modified Rankin Scale (mRS)
Pre-stroke score 1
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1 Participants
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Changes of Daily Activities as Measured by the Modified Rankin Scale (mRS)
Pre-stroke score 2
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1 Participants
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Changes of Daily Activities as Measured by the Modified Rankin Scale (mRS)
Day 42 score 4
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2 Participants
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Changes of Daily Activities as Measured by the Modified Rankin Scale (mRS)
Day 42 score 6
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1 Participants
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Adverse Events
SCENESSE® (Afamelanotide 16mg)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SCENESSE® (Afamelanotide 16mg)
n=6 participants at risk
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.
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|---|---|
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Nervous system disorders
Haemorrhagic transformation stroke
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16.7%
1/6 • Number of events 1 • All adverse events were monitored from baseline until 3 months after the end of treatment, up to 19 weeks.
Patients were advised to report any adverse events to the PI. All adverse events were assessed as unrelated to SCENESSE® (afamelanotide 16 mg).
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Nervous system disorders
Cerebrovascular accident
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16.7%
1/6 • Number of events 1 • All adverse events were monitored from baseline until 3 months after the end of treatment, up to 19 weeks.
Patients were advised to report any adverse events to the PI. All adverse events were assessed as unrelated to SCENESSE® (afamelanotide 16 mg).
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Other adverse events
| Measure |
SCENESSE® (Afamelanotide 16mg)
n=6 participants at risk
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.
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|---|---|
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Gastrointestinal disorders
Constipation
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33.3%
2/6 • Number of events 2 • All adverse events were monitored from baseline until 3 months after the end of treatment, up to 19 weeks.
Patients were advised to report any adverse events to the PI. All adverse events were assessed as unrelated to SCENESSE® (afamelanotide 16 mg).
|
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Gastrointestinal disorders
Nausea
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16.7%
1/6 • Number of events 1 • All adverse events were monitored from baseline until 3 months after the end of treatment, up to 19 weeks.
Patients were advised to report any adverse events to the PI. All adverse events were assessed as unrelated to SCENESSE® (afamelanotide 16 mg).
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Infections and infestations
Urinary tract infection
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16.7%
1/6 • Number of events 1 • All adverse events were monitored from baseline until 3 months after the end of treatment, up to 19 weeks.
Patients were advised to report any adverse events to the PI. All adverse events were assessed as unrelated to SCENESSE® (afamelanotide 16 mg).
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Investigations
Troponin increased
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16.7%
1/6 • Number of events 1 • All adverse events were monitored from baseline until 3 months after the end of treatment, up to 19 weeks.
Patients were advised to report any adverse events to the PI. All adverse events were assessed as unrelated to SCENESSE® (afamelanotide 16 mg).
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Metabolism and nutrition disorders
Decreased appetite
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16.7%
1/6 • Number of events 1 • All adverse events were monitored from baseline until 3 months after the end of treatment, up to 19 weeks.
Patients were advised to report any adverse events to the PI. All adverse events were assessed as unrelated to SCENESSE® (afamelanotide 16 mg).
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Metabolism and nutrition disorders
Hypervolaemia
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16.7%
1/6 • Number of events 1 • All adverse events were monitored from baseline until 3 months after the end of treatment, up to 19 weeks.
Patients were advised to report any adverse events to the PI. All adverse events were assessed as unrelated to SCENESSE® (afamelanotide 16 mg).
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Musculoskeletal and connective tissue disorders
Arthralgia
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16.7%
1/6 • Number of events 1 • All adverse events were monitored from baseline until 3 months after the end of treatment, up to 19 weeks.
Patients were advised to report any adverse events to the PI. All adverse events were assessed as unrelated to SCENESSE® (afamelanotide 16 mg).
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Nervous system disorders
Haemorrhagic transformation stroke
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16.7%
1/6 • Number of events 1 • All adverse events were monitored from baseline until 3 months after the end of treatment, up to 19 weeks.
Patients were advised to report any adverse events to the PI. All adverse events were assessed as unrelated to SCENESSE® (afamelanotide 16 mg).
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Psychiatric disorders
Delirium
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16.7%
1/6 • Number of events 1 • All adverse events were monitored from baseline until 3 months after the end of treatment, up to 19 weeks.
Patients were advised to report any adverse events to the PI. All adverse events were assessed as unrelated to SCENESSE® (afamelanotide 16 mg).
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Additional Information
Clinical Operations Manager
CLINUVEL PHARMACEUTICALS LIMITED
Phone: Tel: +61 3 9660 4900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place