Migraine With AuraPhase 2APAMNCT04063540
Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
A Phase 2 study testing Amiloride in people with Migraine With Aura, run by Centre Hospitalier Universitaire de Nice at 5 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Migraine With Aura
- What is being tested?
- Amiloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 5 sitesFrance
- Study dates
- 11 Aug 2020to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
sylvie ROMETTINO contact
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
Hôpital Pierre Wertheimer
Bron
Geneviève DEMARQUAY, Dr
- Not yet recruiting
CHU Gabriel Montpied
Clermont-Ferrand
Xavier MOISSET, Dr
- Recruiting
AP-HM
Marly
Anne DONNET, Dr
- Recruiting
CHU de Montpellier
Montpellier
Anne DUCROS, Pr
- Recruiting
CHU de NICE
Nice
Michel LANTERI-MINET, Dr
About this study
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.
- Conditions
- Migraine With Aura
- Being tested
- Amiloride, Placebos
- Keywords
- migraine, aura, Amiloride, acid-sensing ion channel
- Medical subject headings
- Migraine with Aura, Migraine Disorders, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmilorideDrug
Treatment by Amiloride vs placebo in crossover
PlacebosDrug
Treatment by Amiloride vs placebo in crossover
| Study group | Role | What they receive |
|---|---|---|
| placebo-amiloride | Other | Patients will be treated for 12 weeks with placebo and then after a 4 week wash-out period, will be treated for 12 weeks with amiloride. Receives: Drug: Amiloride; Drug: Placebos |
| amiloride -placebo | Other | Patients will be treated for 12 weeks with amiloride and then after a 4 week wash-out period, will be treated for 12 weeks with placebo. Receives: Drug: Amiloride; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of attacks with aura, with or without headache.
Measured: 12 weeks
Secondary outcomes (2)
Number of days with migraine headache, with or without aura
Measured: 12 weeks
Functional repercussion
Anxiety and depression score on the Hospital Anxiety and Depression scale scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start11 Aug 2020
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Migraine With AuraStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel LANTERI-MINET, Dr, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063540
- Sponsor's protocol ID
- 16-API-01
- Acronym
- APAM
- Status last verified
- Nov 2025
- First submitted
- 19 Aug 2019
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24042483Ayata 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. doi: 10.1002/ana.20778.
PubMed 16450381Ligthart 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. doi: 10.1375/183242706776403019.
PubMed 16611468
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
- ClinicalTrials.gov ID
- NCT04063540
- Acronym / sponsor ID
- APAM / 16-API-01
- Conditions
- Migraine With Aura
- Keywords
- migraine, aura, Amiloride, acid-sensing ion channel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo-amiloride | Other | Drug: Amiloride, Drug: PlacebosPatients will be treated for 12 weeks with placebo and then after a 4 week wash-out period, will be treated for 12 weeks with amiloride. |
| amiloride -placebo | Other | Drug: Amiloride, Drug: PlacebosPatients will be treated for 12 weeks with amiloride and then after a 4 week wash-out period, will be treated for 12 weeks with placebo. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Existence of contraindication to taking amiloride:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmilorideTreatment by Amiloride vs placebo in crossover | Drug | amiloride -placebo, placebo-amiloride |
| PlacebosTreatment by Amiloride vs placebo in crossover | Drug | amiloride -placebo, placebo-amiloride |
Primary outcome
Number of attacks with aura, with or without headache.
Time frame: 12 weeks
2 secondary outcomes
Number of days with migraine headache, with or without aura
Time frame: 12 weeks
Functional repercussion
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 24042483Charles 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.
- Results publication: PubMed 16450381Ayata 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. doi: 10.1002/ana.20778.
- Results publication: PubMed 16611468Ligthart 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. doi: 10.1375/183242706776403019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
sylvie ROMETTINO contact
Michel LANTERI-MINET, Dr principal investigator
Centre Hospitalier Universitaire de Nice
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amiloride in people with Migraine With Aura, run by Centre Hospitalier Universitaire de Nice at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michel LANTERI-MINET, Dr (04 92 03 76 46, lanteri-minet.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of attacks with aura, with or without headache. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04063540, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.