Migraine with aura MedDRA version: 20.0 Level: PT Classification code 10027607 Term: Migraine with aura System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Modamide 5 mg cp
Product Name: Amiloride
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
CHU de Nice
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of amiloride (non-specific ASIC-1 channel blocker) in the prophylaxis of migraine with aura;Secondary Objective: - 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;Primary end point(s): Number of aura in the last 4 weeks of each therapeutic period;Timepoint(s) of evaluation of this end point: 8 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Timepoint(s) of evaluation of this end point: 8 months | — |
Countries
France
Contacts
Public ContactDr Emilie Piquet
CHU de Nice
Outcome results
None listed