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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of migraine with aura code

At least 1 aura with aura per month in the 3 months prior to inclusion

No prophylactic antimigraine treatment for at least 1 month prior to inclusion

For women of childbearing age, use of a reliable contraceptive method at least 3 months before and 1 month after the study

Disqualifiers

Known hypersensitivity to the molecule

Hyperkalemia (potassium level (> 5.5 mmol / l))

Use of another hyperkalemic diuretic or potassium salts

Renal insufficiency (clearance <60 ml / min)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Amiloride

    Drug

    Treatment by Amiloride vs placebo in crossover

  • Placebos

    Drug

    Treatment by Amiloride vs placebo in crossover

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: placebo-amilorideOther 2 interventions
Group B: amiloride -placeboOther 2 interventions

Trial outcomes

Primary outcomes

1

Number of attacks with aura, with or without headache.

Time frame
12 weeks

Secondary outcomes

1

Number of days with migraine headache, with or without aura

Time frame
12 weeks
2

Functional repercussion

Anxiety and depression score on the Hospital Anxiety and Depression scale scale

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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