Cortical spreading depression and migraine.
Andrew C Charles, Serapio M Baca
https://pubmed.ncbi.nlm.nih.gov/24042483Actively Recruiting
Phase 2
Age: 18Years - 80Years
All Genders
ID04063540
Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-12-04
40
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying migraine with aura to evaluate the effect of amiloride, a drug that blocks Acid-Sensing Ion Channels involved in migraine mechanisms. This proof-of-concept Phase 2 study compares amiloride to placebo to see if it can help prevent migraine aura attacks. The study is conducted at three headache centers in France and aims to explore a new treatment approach for people with this condition. Participants will receive either amiloride or placebo for 12 weeks, followed by a 4-week break, then switch to the other treatment for another 12 weeks. This randomized crossover study allows each participant to try both treatments in sequence. The double-blind design means neither participants nor researchers know which treatment is given at each stage. During the study, researchers will track the number of migraine aura attacks over 12 weeks as the main measure. They will also record migraine headache days and the impact of migraines on daily functioning. Participants will be monitored for safety and treatment adherence throughout the study. The total treatment period for each participant is about 28 weeks, including both treatment phases and the wash-out period.
CONDITIONS
Brief Title
Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of migraine with aura
- At least one aura per month in the three months before joining
- No migraine prevention treatment for at least one month before joining
- Women of childbearing age must use reliable contraception three months before and one month after the study
- Signed informed consent
- Affiliated with Social Security
You will not qualify if you...
- Known allergy to amiloride
- High potassium levels (above 5.5 mmol/L)
- Use of other potassium-increasing diuretics or potassium salts
- Kidney problems with clearance less than 60 ml/min
- Severe liver failure
- Use of lithium, certain blood pressure drugs, ciclosporin, tacrolimus, or drugs causing heart rhythm problems
- Heart or kidney disease in people over 75 years old
- Expected poor compliance with study procedures
- Pregnancy or breastfeeding
- Under legal guardianship or protection by law
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 28 weeks including treatment and wash-out periods
Participants receive treatment by amiloride and placebo in a randomized crossover design with a wash-out period between treatments.
Weekly or regular visits during each 12-week treatment period and 4-week wash-out period
Trial Site Locations
Total: 5 locations
1
Hôpital Pierre Wertheimer
Bron, France
Not Yet Recruiting
2
CHU Gabriel Montpied
Clermont-Ferrand, France
Not Yet Recruiting
3
AP-HM
Marly, France
Actively Recruiting
4
CHU de Montpellier
Montpellier, France
Actively Recruiting
5
CHU de NICE
Nice, France
Actively Recruiting
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Research Team
M
Michel LANTERI-MINET, Dr
S
sylvie ROMETTINO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Suppression of cortical spreading depression in migraine prophylaxis.
Cenk Ayata, Hongwei Jin, Chiho Kudo...
https://pubmed.ncbi.nlm.nih.gov/16450381Migraine with aura and migraine without aura are not distinct entities: further evidence from a large Dutch population study.
Lannie Ligthart, Dorret I Boomsma, Nicholas G Martin...
https://pubmed.ncbi.nlm.nih.gov/16611468