Study Comparing Amitriptyline, Flunarizine, Topiramate, and Propranolol for Preventing Migraines in Primary Care Patients

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What is this study about?

This clinical trial is focused on studying the effectiveness of preventive treatments for migraine, a common type of headache that can cause severe pain and other symptoms like nausea and sensitivity to light and sound. The study will compare several medications that are often used to prevent migraines. These medications include amitriptyline, flunarizine, topiramate, and propranolol. Each of these medications works in different ways to help reduce the frequency and severity of migraine attacks.

The purpose of the study is to evaluate how well these medications work in reducing the number of migraine days each month. Participants in the study will be randomly assigned to receive one of the medications or a placebo. The study will last for 12 weeks, during which participants will take the assigned medication daily. Throughout the study, participants will be asked to keep track of their migraine symptoms and any side effects they experience.

By the end of the study, researchers aim to determine which medication is most effective in preventing migraines in a primary care setting. This information could help doctors make better decisions about which treatments to recommend for patients with migraines. Participants will also provide feedback on their overall experience with the treatment, which will help researchers understand the impact of these medications on daily life.

1 joining the study

Upon joining the study, eligibility is confirmed. Participants must be adults experiencing migraines at least four days per month.

2 initial assessment

An initial assessment is conducted to establish a baseline for the number of monthly migraine days.

3 medication administration

Participants receive one of the following medications: amitriptyline, flunarizine, topiramate, or propranolol. All medications are taken orally.

The dosage and frequency are determined by the study protocol and are administered consistently throughout the trial.

4 treatment period

The treatment period lasts for 12 weeks. During this time, the effectiveness of the medication is monitored by tracking changes in the number of monthly migraine days.

5 midpoint evaluations

Evaluations occur at 4 and 8 weeks to assess changes in migraine frequency and severity. Adjustments to treatment may be made based on these evaluations.

6 final assessment

At the end of 12 weeks, a final assessment is conducted to evaluate the overall effectiveness of the treatment. This includes measuring the change in the number of monthly migraine days and assessing any associated symptoms such as sensitivity to light or sound and nausea.

7 follow-up

Participants are monitored for adherence to the treatment plan and any changes in medication use. Follow-up assessments may occur up to 6 months after the trial to evaluate long-term effects and adherence.

Who Can Join the Study?

You must be an adult, which means you are 18 years old or older.
You should be a candidate for preventive treatment for migraine. This means you are looking to reduce the number of migraine days you have each month.
You need to have at least 4 migraine days each month.
You must agree to participate in the clinical trial, which means you are willing to follow the study’s rules and procedures.
Both men and women can participate in this study.

Who Cannot Join the Study?

Individuals who are not within the specified age range for the study.
Individuals who have medical conditions other than migraine that could interfere with the study.
Individuals who are currently taking medications that might affect the study results.
Individuals who have a history of allergic reactions to the medications being tested in the study.
Individuals who are pregnant or breastfeeding.
Individuals who have participated in another clinical trial recently.
Individuals who have a history of substance abuse or addiction.
Individuals who have a serious mental health condition that could affect their ability to participate in the study.
Individuals who are unable to comply with the study procedures or follow-up visits.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Socm Maxad dl Pmgdxmbhsv	Barcelona	Spain
Chx Eq Cndhenh	Castelldefels	Spain
Csl Dxj Mhkuz i Jfrge	Cornellà de Llobregat	Spain
Cxd Cbk Mhzahb	Cornellà de Llobregat	Spain
Cwj Lg Fveojqg	L'hospitalet De Llobregat	Spain
Cio Rmspjw	Sant Feliu de Llobregat	Spain
Cea Sytx Iekhijqy	Cornellà de Llobregat	Spain
Cww Sidbk Cnxyjo dx Qybqqhd	Santa Coloma de Queralt	Spain
Cei Cfvcm dg Mvz	Canet de Mar	Spain
Cfp Ctstoogu dn Ldwlofoog	Cornellà de Llobregat	Spain
Cpr Bgnewyyxtvugiiuguqaeyu da Sdos Pdkq	Lleida	Spain
Cxe Anazhk Tacpma	L'hospitalet De Llobregat	Spain
Cha Ez Trznpv &svhiqp Teafpfk Eez	Tortosa	Spain
Cur Svzyo Ccefs	Girona	Spain
Cdf La Sityqew	Barcelona	Spain
Cdc Ly Gzmnbf	Molins de Rei	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Amitriptyline is a medication commonly used to prevent migraines. It works by affecting certain chemicals in the brain that may be involved in causing migraine headaches. It is often chosen for its ability to reduce the frequency and severity of migraine attacks.

Flunarizine is a medication that helps prevent migraines by blocking calcium channels in the brain. This action can help reduce the number of migraine days by preventing the constriction of blood vessels, which is thought to play a role in migraine development.

Topiramate is a medication used to prevent migraines. It works by stabilizing electrical activity in the brain and reducing the frequency of migraine attacks. It is often used for its effectiveness in decreasing the number of migraine days.

Propranolol is a medication that is often used to prevent migraines. It is a type of beta-blocker that helps to relax blood vessels and improve blood flow, which can help reduce the frequency and intensity of migraine headaches.

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often on one side of the head. These headaches can be accompanied by symptoms such as nausea, vomiting, and sensitivity to light and sound. Migraine attacks can last from a few hours to several days and may vary in frequency and intensity. Some individuals experience warning symptoms, known as aura, before the onset of a migraine. The condition can significantly impact daily activities and quality of life. Migraine is a common condition, affecting people of all ages, and can be influenced by genetic and environmental factors.

Trial ID:

2024-513597-22-00

Protocol code:

IJG-PREMI-2024

NCT ID:

NCT06499116

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Amitriptyline, Flunarizine, Topiramate, and Propranolol for Preventing Migraines in Primary Care Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?