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RECRUITING
NCT04063540
PHASE2

Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura

Sponsor: Centre Hospitalier Universitaire de Nice

View on ClinicalTrials.gov

Summary

Recent data suggest involvement of Acid-Sensing Ion Channel channels in the pathophysiology of migraine making these channels a therapeutic target of migraine disease. The implication of Acid-Sensing Ion Channels is discussed through Acid-Sensing Ion Channel-1 which is the most expressed Acid-Sensing Ion Channel channel subtype in the central nervous system. In a mouse model, cortical spreading depression is inhibited by different Acid-Sensing Ion Channel blockers including amiloride which is a non-selective blocker of the Acid-Sensing Ion Channel-1 channel. From a translational perspective, an efficacy of amiloride on a series of migraine patients suffering from severe aura in open conditions. The APAM study is a proof-of-concept study that aims to evaluate the effect of amiloride in the prophylaxis of migraine with aura. This is a randomized crossover study versus placebo conducted in 3 French headache centers.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-08-11

Completion Date

2027-12

Last Updated

2025-12-04

Healthy Volunteers

No

Interventions

DRUG

Amiloride

Treatment by Amiloride vs placebo in crossover

DRUG

Placebos

Treatment by Amiloride vs placebo in crossover

Locations (5)

Hôpital Pierre Wertheimer

Bron, France

CHU Gabriel Montpied

Clermont-Ferrand, France

AP-HM

Marly, France

CHU de Montpellier

Montpellier, France

CHU de NICE

Nice, France