Study of Amiloride tablets for prevention of migraine with aura attacks

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What is this study about?

This study focuses on patients with migraine with aura, a specific type of headache condition where visual or other neurological symptoms occur before or during the headache. The research examines the effectiveness of amiloride, a medication that blocks certain channels in the brain, to prevent migraine aura from occurring.

The study will test whether taking amiloride tablets can reduce the frequency of migraine attacks with aura. The medication will be taken orally each day for three months, with a maximum daily dose of 10 mg. The total amount of medication received during the entire study period will not exceed 900 mg.

The research aims to understand if blocking specific brain channels with amiloride can help prevent the occurrence of migraine aura symptoms. During the study, participants will need to track their migraine episodes and any changes in their condition. The study will also monitor how the treatment affects daily activities and overall well-being.

1 Initial phase

You will receive Modamide tablets containing 5 mg of amiloride for oral use

The treatment aims to prevent migraine auras – visual or sensory disturbances that occur before or during migraine headaches

The study will evaluate how well amiloride works in reducing the frequency of migraine auras

2 Treatment monitoring

Your progress will be tracked by recording:

– Number of migraine auras you experience, with or without headache

– Number of days you have migraine headaches

– Number of days you have any type of headache

You will complete several questionnaires to assess:

– How migraines affect your daily activities (using HIT-6 scale)

– Your emotional well-being (using HAD scale)

– Your overall health status (using EQ-5D scale)

3 Safety monitoring

Any unusual symptoms or side effects you experience will be documented

If you are a woman of childbearing age, you must use reliable contraception during the study and for one month after

The study duration may extend until December 2025

4 Important requirements

You must have experienced at least one migraine with aura per month in the previous 3 months

You cannot be taking other migraine prevention medications during the study

You must be between 18 and 80 years old

You must have social security coverage

Who Can Join the Study?

Age between 18 and 80 years old
Can be either male or female
Must have a confirmed diagnosis of migraine with aura (a condition where headaches are preceded by sensory disturbances like flashing lights, blind spots, or tingling sensations)
Must experience at least 1 migraine with aura attack per month in the past 3 months
Must not have used any preventive migraine medications for at least 1 month before joining the study
Women who can become pregnant must use reliable contraception for at least 3 months before and 1 month after the study
Must be willing to sign an informed consent form to participate in the study
Must have active social security coverage

Who Cannot Join the Study?

Age below 18 or above 65 years
Pregnancy or breastfeeding
History of allergic reactions to amiloride (the study medication) or similar drugs
Current use of medications that could interact with amiloride
Severe kidney or liver problems
Uncontrolled high blood pressure
History of heart disease or heart rhythm problems
Other types of headaches that could be confused with migraines
Participation in another clinical trial within the last 30 days
Mental health conditions that could affect the ability to provide informed consent
History of substance abuse within the past year
Inability to follow study procedures or attend scheduled visits
Medical conditions that could interfere with the evaluation of the study medication
Use of other migraine prevention medications that cannot be safely stopped
History of stroke or other serious neurological conditions

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Jean Perrin	Clermont Ferrand	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Azsiematpo Pmouwxuy Hupfqxyk De Mdymkwwbt	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	11.08.2020

Trial locations

Investigated drugs:

Amiloride Hydrochloride Dihydrate

Amiloride is a medication that works by blocking specific channels in nerve cells called ASIC-1 channels. It is primarily used to treat high blood pressure and heart conditions, but in this trial, it is being studied as a preventive treatment for migraine auras. Migraine auras are sensory disturbances that some people experience before a migraine headache begins, such as seeing flashing lights or experiencing numbness. The medication aims to reduce the frequency and severity of these aura symptoms by regulating the activity of nerve cells in the brain.

Migraine with aura – A neurological condition characterized by recurring headaches preceded by sensory disturbances called aura. The aura typically involves visual symptoms such as flashing lights, zigzag lines, or blind spots, but can also include other sensory changes. These warning symptoms usually develop gradually over several minutes and can last up to an hour before the headache begins. The headache phase is often accompanied by sensitivity to light and sound, nausea, and may affect one or both sides of the head. Episodes can last from several hours to days, with varying frequency among individuals.

Trial ID:

2024-516044-25-00

Protocol code:

16-API-01

NCT ID:

NCT04063540

Trial Phase:

Therapeutic use (Phase IV)

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Study of Amiloride tablets for prevention of migraine with aura attacks

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