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

Primary Purpose

Migraine With Aura

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Amiloride
Placebos
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine With Aura focused on measuring migraine, aura, Amiloride, acid-sensing ion channel

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AP-HM
  • CHU de Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

placebo-amiloride

amiloride -placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of attacks with aura, with or without headache.

Secondary Outcome Measures

Number of days with migraine headache, with or without aura
Functional repercussion
Anxiety and depression score on the Hospital Anxiety and Depression scale scale

Full Information

First Posted
August 19, 2019
Last Updated
August 20, 2019
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT04063540
Brief Title
Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura
Keywords
migraine, aura, Amiloride, acid-sensing ion channel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo-amiloride
Arm Type
Other
Arm Description
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.
Arm Title
amiloride -placebo
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Amiloride
Intervention Description
Treatment by Amiloride vs placebo in crossover
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Treatment by Amiloride vs placebo in crossover
Primary Outcome Measure Information:
Title
Number of attacks with aura, with or without headache.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of days with migraine headache, with or without aura
Time Frame
12 weeks
Title
Functional repercussion
Description
Anxiety and depression score on the Hospital Anxiety and Depression scale scale
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie PIQUET, Dr
Phone
04 92 03 84 74
Email
piquet.e@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Michel LANTERI-MINET, Dr
Phone
04 92 03 79 46
Email
lanteri-minet.m@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie PIQUET, Dr
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
AP-HM
City
Marly
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne DONNET, Dr
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne DUCROS, Pr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24042483
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.
Results Reference
background
PubMed Identifier
16450381
Citation
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. doi: 10.1002/ana.20778.
Results Reference
result
PubMed Identifier
16611468
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. doi: 10.1375/183242706776403019.
Results Reference
result

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

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