E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute ischaemic stroke |
Akuutti aivoinfarkti |
|
E.1.1.1 | Medical condition in easily understood language |
Acute ischaemic stroke |
Akuutti aivoinfarkti |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare neurological impairment (NIHSS) at 7 days in treated and untreated patients.
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E.2.2 | Secondary objectives of the trial |
To determine the effect on the longer term (Day 90) clinical outcomes of neurological disability (NIHSS, modified Rankin Scale [mRS]), and death, and investigate the effect of Exenatide on the acute stroke dynamic glucose profile using continuous glucose monitoring. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Males and females 18 years or older - Acute Ischaemic stroke – (CT to exclude haemorrhagic stroke) - Blood sugar level on admission ≥ 4mmol/L - First trial treatment possible within 9 hours of stroke onset - Pre-morbid modified Rankin Scale (mRS) score of 0-2 |
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E.4 | Principal exclusion criteria |
- Haemorrhagic stroke - Poor clinical prognosis /palliation. (Judged to be unlikely to survive beyond 14 days post stroke) - Any known allergy or hypersensitivity to Exenatide - Females who are pregnant (known or suspected) or currently breastfeeding - Any past history of pancreatitis or evidence of active pancreatitis - History of active severe gastrointestinal disease (including but not limited to gastroparesis and dumping syndrome) - Current chronic kidney disease stage 4 or 5 (creatinine clearance <30ml/min) - Current participation in another interventional clinical trial. - Inability to provide consent (participant or person responsible as local laws apply) - Current use of Exenatide (Byetta®), or other GLP-1 agonist diabetes medication - Patients considered unlikely to be able to be followed up at 3 months (including but not limited to geographical location of patient at 3 months) |
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E.5 End points |
E.5.1 | Primary end point(s) |
≥ 8 point improvement in National Institutes of Health Stroke Scale (NIHSS) stroke impairment score (or NIHSS 0-1) at 7 days |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Reduced frequency of hyper- and hypoglycaemia at 5 days - Death at Day 90 - Modified Rankin Scale (mRS) at Day 90 - National Institutes of Health Stroke Scale (NIHSS) at Day 90 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
prospective, randomised, open label, blinded end-point (PROBE) |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |