E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acute stroke (cerebral infarction or intracrebral hemorrhage) and a body temperature of 36.5 degrees or above. |
Acute beroerte (herseninfarct of hersenbloeding) en een lichaamstemperatuur van 36.5 graden Celsius of hoger |
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E.1.1.1 | Medical condition in easily understood language |
acute stroke (cerebral infarction or intracrebral hemorrhage) and a body temperature of 36.5 degrees or above. |
Acute beroerte (herseninfarct of hersenbloeding) en een lichaamstemperatuur van 36.5 graden Celsius of hoger |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042244 |
E.1.2 | Term | Stroke |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 assess the effect of early treatment with paracetamol in a daily dose of 6 g for three consecutive days in patients with acute stroke and a body temperature of 36.5°C or above on the occurrence of a favorable functional outcome.
|
Het effect vaststellen van vroege behandeling met paracetamol, 6 gram per dag voor drie dagen, bij patienten in de acute fase van een beroerte en een lichaamstemperatuur van 36.5 graden Celsius of hoger |
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E.2.2 | Secondary objectives of the trial |
1. To investigate the association between body temperature in the first 12-36 hours after acute stroke and serum inflammation markers. 2. To investigate the relationship between paracetamol in a daily dose of 6 g for three days and an inflammatory response in stroke. |
1. Het verband onderzoeken tussen lichaamstemperatuur in de eerste 12-36 uur na een beroerte en serum inflammatie markers. 2. Het verband onderzoeken tussen paracetamol in een dagelijkse dosering van 6 gram gedurende 3 dagen en de inflammatoire respons bij beroertes. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- clinical diagnosis of ischemic stroke or intracerebral hemorrhage, confirmed by CT or MRI scan within 24 hours after inclusion in the study - a measurable deficit on the National Institutes of Health Stroke Scale (NIHSS) - the possibility to start treatment within 12 hours of symptom onset (for patients who noticed symptoms when awaking from sleep, the time last seen well is taken as the time of onset of symptoms) - a body temperature of 36.5°C or higher - age of 18 years or older - signed informed consent |
- klinische diagnose van herseninfact of - bloeding, bevestigd door CT of MRI scan binnen 24 uur na inclusie in het onderzoek - een meetbare afwijking op de NIHSS (National Institutes of Health Stroke Scale) - start van de behandeling is mogelijk binnen 12 uur na het ontstaan van de symptomen (bij patienten die de symptomen bemerkten toen ze wakker werden, wordt de tijd dat ze voor het laatst goed gezien zijn als tijdstip van ontstaan van de symptomen genomen.) - een lichaamstemperatuur van 36.5 graden Celsius of hoger - leeftijd 18 jaar of ouder - getekend toestemmingsformulier |
|
E.4 | Principal exclusion criteria |
- a body temperature lower then 37.0°C - a history of liver disease or alcohol abuse - liver enzymes (ASAT, ALAT, AP or gamma-GT) increased above twice the upper limit of normal values - allergy to paracetamol - death appearing imminent at the time of inclusion - any pre-stroke impairment that has led to dependency (modified Rankin scale (mRS)>2) and therefore interferes with the assessment of functional outcome. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome will be improvement beyond expectation on the mRS at 3 months. |
De primaire uitkomstmaat is verbetering op de modified Rankin scale (mRS), gemeten na 3 maanden. |
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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) |
The secondary outcomes will be poor outcome defined as mRS>2 at 3 months; score on the Barthel index and EQ5D score at 3 months; and body temperature 24 hours after start of treatment. |
De secundaire uitkomstmaten zijn: een slechte functionele uitkomst (mRS >2) na 3 maanden, de score op de Barthel index en EQ5D na 3 maanden en lichaamstemperatuur 24 uur na start van de behandeling. |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
|
see the protocol, it is indeed last visit of last subject included in the trial. |
zie het protocol, het is inderdaad de laatste controle van de laatste proefpersoon van het onderzoek |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |