ASIC channels and migraine disorders - Proof of concept study on the efficacy of Amiloride in prophylaxis of Migraine with Aura - APAM study

Phase 1

• Conditions: Migraine with aura; MedDRA version: 20.0Level: PTClassification code 10027607Term: Migraine with auraSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2017-001288-18-FR
• Lead Sponsor: CHU de Nice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-06
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- Evaluate the efficacy of amiloride by measuring the functional impact in migraine with aura prophylaxis<br>- Evaluate the efficacy of amiloride by measuring the emotional impact in migraine with aura prophylaxis<br>- Evaluate the efficacy of amiloride by measuring state of health in migraine with aura prophylaxis<br>- 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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Analysis of the number of days with headache, with or without aura.<br>- Impact score on the HIT-6 scale<br>- Anxiety and depression score on the HAD scale<br>- EQ-5D Scale Score<br>- Occurrence or absence of significant or unknown adverse events;Timepoint(s) of evaluation of this end point: 8 months