E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Migraine with aura |
Migraine avec aura |
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E.1.1.1 | Medical condition in easily understood language |
Migraine with aura |
Migraine avec aura |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027607 |
E.1.2 | Term | Migraine with aura |
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 |
Evaluate the efficacy of amiloride (non-specific ASIC-1 channel blocker) in the prophylaxis of migraine with aura |
Evaluer l’efficacité de l’amiloride (bloqueur non spécifique des canaux ASIC-1) dans la prophylaxie de l’aura migraineuse |
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E.2.2 | Secondary objectives of the trial |
- Evaluate the efficacy of amiloride in the prophylaxis of migraine headache - Evaluate the efficacy of amiloride by measuring the functional impact in migraine with aura prophylaxis - Evaluate the efficacy of amiloride by measuring the emotional impact in migraine with aura prophylaxis - Evaluate the efficacy of amiloride by measuring state of health in migraine with aura prophylaxis - Evaluate the safety use of amiloride in migraine with aura prophylaxis |
- Evaluer l’efficacité de l’amiloride dans la prophylaxie de la céphalée migraineuse - Evaluer l’efficacité de l’amiloride par la mesure du retentissement fonctionnel dans la prophylaxie de la migraine avec aura - Evaluer l’efficacité de l’amiloride par la mesure du retentissement émotionnel dans la prophylaxie de la migraine avec aura - Evaluer l’efficacité de l’amiloride par la mesure de l’état de santé dans la prophylaxie de la migraine avec aura - Evaluer la sécurité d’emploi de l’amiloride dans la prophylaxie de la migraine avec aura |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subjects aged 18 to 80 years - Male or female - Diagnosis of migraine with aura code 1.2.1 according to ICHD-3 including codes 1.2.1.1.1 and 1.2.1.2 - At least 1 crisis with aura per month in the 3 months prior to inclusion - No prophylactic migraine background treatment for at least 1 month before inclusion - For women of childbearing age, use of a reliable contraceptive method at least 3 months before and 1 month after the study - Signing of written informed consent - Patient affiliated to social security |
- Sujets âgés de 18 à 80 ans - Homme ou femme - Diagnostic de migraine avec aura code 1.2.1 selon l’ICHD-3 incluant les codes 1.2.1.1 et 1.2.1.2 - Au moins 1 crise avec aura par mois dans les 3 mois précédant l’inclusion - Absence de traitement de fond prophylactique antimigraineux depuis au moins 1 mois avant l’inclusion - Pour les femmes en âge de procréer, utilisation d’une méthode contraceptive fiable au moins 3 mois avant et 1 mois après l’étude - Signature du consentement éclairé écrit - Patient affilié à la sécurité sociale |
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E.4 | Principal exclusion criteria |
- Existence of contraindications to taking amiloride: - Known hypersensitivity to the molecule - Hyperkalemia - Use of another hyperkalemic diuretic or potassium salts - Renal insufficiency (clearance < 60 ml/min) - Severe hepatocellular insufficiency - Patient, who from the investigator's point of view would not be compliant with the study procedure - Pregnant or breastfeeding patient - Patient under guardianship, protected by law |
- Existence de contre-indication à la prise d’amiloride : - Hypersensibilité connue à la molécule - Hyperkaliémie - Utilisation d’un autre diurétique hyperkaliémiant ou de sels de potassium - Insuffisance rénale (clairance < 60 ml/min) - Insuffisance hépato cellulaire sévère - Patient, qui d’un point de vue de l’investigateur ne serait pas compliant à la procédure de l’étude - Patiente enceinte ou allaitante - Patient sous tutelle, sous curatelle, protégé par la loi |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of aura in the last 4 weeks of each therapeutic period |
Nombre d’aura au cours des 4 dernières semaines de chaque période thérapeutique |
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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) |
- Analysis of the number of days with headache, with or without aura. - Impact score on the HIT-6 scale - Anxiety and depression score on the HAD scale - EQ-5D Scale Score - Occurrence or absence of significant or unknown adverse events |
- Analyse du nombre de jours avec céphalée, avec ou sans aura. - Score d’impact sur l’échelle HIT-6 - Score d’anxiété et de dépression sur l’échelle HAD - Score de l’échelle EQ-5D - Survenue ou absence d’effets indésirables notables ou non connus |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | 3 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |