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

Migraine With Aura Clinical Trial

— APAM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04063540
• Other study ID #: 16-API-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2019
• Est. completion date: November 2021

Study information

• Verified date: August 2019
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Emilie PIQUET, Dr
• Phone: 04 92 03 84 74
• Email: piquet.e[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2021
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

• Signature of written informed consent

• Patient affiliated with Social Security

Exclusion Criteria:

• Existence of contraindication to taking amiloride:

• 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)

• Severe hepatocellular insufficiency

• In combination with lithium, converting enzyme inhibitors, angiotensin II inhibitors (except if there is hypokalemia), ciclosporin, tacrolimus, non-antiarrhythmic drugs giving torsades de pointes

• Cardiovascular and renal history, for subjects over 75 years old

• Patient, who from an investigator's point of view would not be compliant to the procedure of the study

• Pregnant or lactating patient

• Patient under trusteeship, under guardianship, protected by law

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine with Aura

Intervention

Drug:
• Amiloride
Treatment by Amiloride vs placebo in crossover
• Placebos
Treatment by Amiloride vs placebo in crossover

Locations

Country	Name	City	State
France	AP-HM	Marly
France	CHU de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

References & Publications (3)

Ayata C, Jin H, Kudo C, Dalkara T, Moskowitz MA. Suppression of cortical spreading depression in migraine prophylaxis. Ann Neurol. 2006 Apr;59(4):652-61. — View Citation

Charles AC, Baca SM. Cortical spreading depression and migraine. Nat Rev Neurol. 2013 Nov;9(11):637-44. doi: 10.1038/nrneurol.2013.192. Epub 2013 Sep 17. Review. — View Citation

Ligthart L, Boomsma DI, Martin NG, Stubbe JH, Nyholt DR. Migraine with aura and migraine without aura are not distinct entities: further evidence from a large Dutch population study. Twin Res Hum Genet. 2006 Feb;9(1):54-63. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of attacks with aura, with or without headache.		12 weeks
Secondary	Number of days with migraine headache, with or without aura		12 weeks
Secondary	Functional repercussion	Anxiety and depression score on the Hospital Anxiety and Depression scale scale	12 weeks