Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

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

Registered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

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

  2. Step 2

    Initial assessment

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

  3. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

9 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

  • Amitriptyline

    Amitriptyline is typically administered orally in tablet form. It is currently used in medicine as a preventive treatment for migraines, with a well-established presence in medical literature. Its main therapeutic indication is to reduce the frequency of migraine attacks. At the molecular level, amitriptyline works by increasing the levels of certain neurotransmitters in the brain, which helps to stabilize mood and reduce pain perception. It is classified as a tricyclic antidepressant.

  • Flunarizine

    Flunarizine is administered orally, usually in capsule form. It is recognized in medical literature as a preventive treatment for migraines. The primary therapeutic indication is to decrease the number of migraine days experienced by patients. Flunarizine acts by blocking calcium channels, which helps to prevent the constriction of blood vessels in the brain, thereby reducing migraine frequency. It is classified as a calcium channel blocker.

  • Topiramate

    Topiramate is taken orally, often in tablet or capsule form. It is widely used in medicine for the prevention of migraines and is well-documented in medical literature. The main therapeutic indication is to lower the number of migraine episodes. Topiramate works by stabilizing electrical activity in the brain and inhibiting certain neurotransmitters, which helps to prevent migraine attacks. It is classified as an anticonvulsant.

  • Propranolol

    Propranolol is administered orally, typically in tablet form. It is a well-known medication in medical literature for the prevention of migraines. The primary therapeutic indication is to reduce the frequency and severity of migraine headaches. Propranolol works by blocking beta-adrenergic receptors, which helps to relax blood vessels and decrease the heart rate, thereby reducing migraine occurrence. It is classified as a beta-blocker.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513597-22-00Protocol codeIJG-PREMI-2024Estimated enrolment460 patientsSponsorInstitut Universitari D Investigacio En Atencion Primaria Jordi Gol

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.