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Migraine with aura – Trials in Disease

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Ongoing Clinical Trials for Migraine with Aura

There are currently 8 clinical trials investigating new treatments for migraine with aura. These studies are testing medications aimed at preventing attacks or treating symptoms, primarily in Europe. The trials involve both adults and children, examining drugs such as amiloride, atogepant, and rimegepant. (Also known as: Migraine with visual aura, Classical migraine)

Clinical trial locations

Study of Amiloride tablets for prevention of migraine with aura attacks

This French study is investigating whether amiloride, a medication traditionally used to treat high blood pressure, can help prevent the aura phase of migraines. Aura refers to the visual or sensory disturbances that some people experience before or during a migraine headache.

Inclusion criteria: Participants must be adults aged 18 to 80 years with a confirmed diagnosis of migraine with aura. They should experience at least one attack per month and must not have used preventive migraine medications for at least one month before joining. Women of childbearing age must use reliable contraception, and all participants need active social security coverage.

Exclusion criteria: The study excludes people with severe kidney or liver problems, uncontrolled high blood pressure, heart disease, or a history of stroke. Those with allergic reactions to amiloride, current use of interacting medications, pregnancy or breastfeeding, mental health conditions affecting consent, substance abuse history, or other serious neurological conditions cannot participate.

Trial focus: The study examines whether blocking specific brain channels with amiloride can reduce the frequency of migraine aura symptoms. Participants will take up to 10 mg daily for three months while tracking their migraine episodes and completing questionnaires about how the condition affects their daily activities and emotional well-being.

Investigational drug: Amiloride works by blocking ASIC-1 channels in nerve cells. The study tests whether this mechanism can prevent the sensory disturbances that occur before migraine headaches, potentially offering a new approach to managing this challenging condition.

Study on Atogepant for Treating Migraine in Patients: Evaluating Effectiveness and Safety

This multinational European study compares atogepant to placebo for treating individual migraine attacks. The trial uses a double-blind design, meaning neither participants nor researchers know who receives the actual medication during the initial phase.

Inclusion criteria: Adults aged 18 to 75 years who have experienced migraines lasting 4 to 72 hours for at least 12 months are eligible. Participants should have 2 to 8 migraine attacks per month with moderate to severe pain, with at least 48 hours of no pain between episodes. Previous use of migraine medication is required. Women of childbearing age must have negative pregnancy tests and use approved birth control methods.

Exclusion criteria: People with serious health conditions that might interfere with study results, those taking medications that could interact with the study drug, pregnant or breastfeeding women, recent participants in other clinical trials, and individuals with substance abuse or uncontrolled mental health conditions are excluded.

Trial focus: The study assesses how well atogepant relieves headache pain and helps participants return to normal activities. Participants take a 60 mg tablet when experiencing a migraine attack and record their symptoms in an electronic diary. Key assessments occur at 2 and 8 hours after taking the medication.

Investigational drug: Atogepant blocks calcitonin gene-related peptide (CGRP), a protein involved in migraine pain transmission. The trial includes an open-label extension phase where all participants can receive atogepant to evaluate its long-term effects.

Study on Long-Term Safety and Tolerability of Atogepant for Children and Teens (Ages 6-17) with Migraine

This study focuses on understanding the long-term safety of atogepant in children and teenagers aged 6 to 17 years who experience migraines. The research aims to determine whether this preventive medication can be used safely over an extended period in young patients.

Inclusion criteria: Children and teenagers aged 6 to 17 with a history of episodic or chronic migraine for at least 6 months can participate. They must have completed specific earlier studies and weigh between 20 kg and 135 kg. The trial is open to participants with migraines either with or without aura.

Exclusion criteria: Young people outside the specified age range, those without a migraine diagnosis, anyone unable to follow study procedures, those with other medical conditions that might make participation unsafe, participants in other clinical trials, and those with allergies to the study medication are excluded. Pregnant or breastfeeding individuals and those with uncontrolled psychiatric disorders also cannot participate.

Trial focus: The study monitors participants over an extended period through regular check-ups including blood tests, heart monitoring, and vital sign measurements. Researchers will assess behavioral changes using specialized tools and track any adverse events. The goal is to provide comprehensive data on the medication’s long-term effects in young people.

Investigational drug: Atogepant works by blocking specific receptors in the brain involved in migraine development. This CGRP receptor antagonist is taken as a daily oral tablet to help reduce the frequency and severity of migraine attacks in children and teenagers.

Study on Rimegepant for Treating Acute Migraine in Children and Adolescents Aged 6 to 17 Years

This trial evaluates rimegepant, a medication that dissolves in the mouth, for treating acute migraine attacks in young people. The study compares rimegepant to placebo to understand its effectiveness in providing quick relief from migraine symptoms.

Inclusion criteria: Participants must be aged 6 to 18 years with a history of migraines for more than 6 months, experiencing 1 to 8 moderate or severe attacks per month that last more than 3 hours without treatment. They must be able to distinguish migraines from other headache types and weigh more than 40 kg. Those taking preventive medications must have been on a stable dose for at least 12 weeks.

Exclusion criteria: People with allergies to the study medication, those taking interfering medications, individuals with certain medical conditions making participation unsafe, pregnant or breastfeeding females, recent participants in other trials, and those unable to follow study procedures are excluded.

Trial focus: The study evaluates pain freedom at 2 hours after taking the medication and monitors for side effects. Participants receive either 25 mg or 75 mg doses of rimegepant or placebo during migraine attacks. The trial assesses not only pain relief but also freedom from bothersome symptoms like nausea and sensitivity to light and sound.

Investigational drug: Rimegepant is a CGRP receptor antagonist administered as an oral lyophilisate that dissolves quickly in the mouth. It works by blocking proteins involved in migraine pain and inflammation, aiming to provide rapid relief from acute attacks.

Study on the Long-Term Safety of Rimegepant for Treating Acute Migraine in Children and Adolescents Aged 6 to 17 Years

This open-label study examines the long-term safety of rimegepant when used repeatedly to treat acute migraine attacks in children and adolescents. Unlike the previous rimegepant trial, this study focuses on extended use over time rather than single-attack effectiveness.

Inclusion criteria: Participants must be aged 6 to 18 years with a history of migraines for more than 6 months, experiencing 1 to 8 moderate or severe attacks per month. They must have experienced at least one migraine day requiring treatment during an observation phase. Those on preventive medications need stable doses for at least 12 weeks. Participants must weigh more than 40 kg and be able to distinguish migraines from other headaches.

Exclusion criteria: The study excludes those outside the specified age range, people with medical conditions other than acute migraine, those unable to follow study procedures, recent participants in other trials, individuals with allergies to the medication, pregnant or breastfeeding females, and those taking interfering medications.

Trial focus: The study monitors the frequency and severity of adverse events through regular follow-up visits. Blood samples are taken to establish baseline values and identify any significant laboratory abnormalities. The research tracks how well children and adolescents tolerate repeated use of rimegepant over an extended period.

Investigational drug: Rimegepant is available in 25 mg and 75 mg oral lyophilisate forms. As a CGRP receptor antagonist, it blocks the calcitonin gene-related peptide receptor involved in migraine headache development, providing relief when taken during acute attacks.

Study on the Safety and Effectiveness of Atogepant for Preventing Episodic Migraine in Children and Teens Aged 6 to 17

This double-blind study tests whether daily atogepant can reduce the number of migraine days in children and teenagers with episodic migraine. Episodic migraine occurs less than 15 days per month, distinguishing it from chronic forms of the condition.

Inclusion criteria: Participants aged 6 to 17 years must weigh between 20 kg and 135 kg and have a history of episodic migraine for at least 6 months. They must have experienced 4 to 14 migraine days and fewer than 15 headache days in the previous 28 days, as recorded in an electronic diary.

Exclusion criteria: Those with allergies to the study medication, people taking interfering medications, individuals with serious health conditions, recent participants in other clinical trials, pregnant or breastfeeding females, those with substance abuse history, and people with mental health conditions that could interfere with following study instructions are excluded.

Trial focus: The study evaluates whether atogepant reduces migraine days over a 12-week period. Participants are randomly assigned to receive either 10 mg, 60 mg, or placebo daily. Throughout the trial, participants record their migraine and headache days in an electronic diary, along with any medication use.

Investigational drug: Atogepant tablets are taken once daily for 12 weeks. This CGRP receptor antagonist works by blocking specific receptors in the brain involved in migraine development, aiming to prevent attacks before they start and improve quality of life in young patients.

Study Comparing Atogepant and Topiramate for Preventive Treatment in Adults with Migraine

This head-to-head comparison study evaluates atogepant against topiramate, an established migraine prevention medication. The trial aims to determine whether atogepant offers similar or better effectiveness with potentially fewer side effects.

Inclusion criteria: Adults with a documented history of migraine for at least 12 months who experience at least 4 migraine days per month and need preventive treatment can participate. The study accepts both males and females, including those from vulnerable populations.

Exclusion criteria: People unable to follow study instructions, those with severe allergies to study medications, recent users of other migraine prevention treatments, individuals with certain interfering medical conditions, pregnant or breastfeeding women, current participants in other trials, those with drug or alcohol abuse history, people planning surgery, and individuals with uncontrolled high blood pressure or certain heart conditions are excluded.

Trial focus: The double-blind treatment period lasts 24 weeks, during which researchers assess treatment discontinuation due to adverse events as the primary measure. The study evaluates the reduction in average migraine days per month during months 4 to 6, along with changes in headache impact and quality of life scores.

Investigational drugs: Atogepant works by blocking CGRP receptors involved in migraine development, while topiramate stabilizes electrical activity in the brain. Both are taken orally as tablets. The study includes an open-label extension phase to further evaluate long-term safety.

Study on Long-Term Safety of Atogepant for Preventing Migraine in Patients with Chronic or Episodic Migraine

This open-label study examines the long-term safety of atogepant over a period of 156 weeks (approximately 3 years) in adults with either chronic or episodic migraine. The extended duration allows researchers to gather comprehensive data on prolonged medication use.

Inclusion criteria: Adults must have completed specific visits from earlier related studies without significant issues. They must be diagnosed with chronic or episodic migraine and must not have experienced serious side effects suggesting the treatment is unsafe for them.

Exclusion criteria: People with other serious health conditions that might interfere with the study, current participants in other clinical trials, pregnant or breastfeeding women, those planning surgery, individuals with recent drug or alcohol abuse, people with allergies to the medication, those unable to comply with study procedures, individuals with uncontrolled mental health disorders, and those who recently used interfering medications are excluded.

Trial focus: Participants take a 60 mg oral tablet of atogepant once daily for up to 156 weeks. Regular check-ups monitor laboratory values, heart function through electrocardiograms, and vital signs. The study tracks any treatment-emergent adverse events to ensure long-term safety.

Investigational drug: Atogepant is a CGRP receptor antagonist that blocks specific proteins in the brain involved in migraine development. By taking this medication daily over an extended period, the study aims to determine whether it remains safe and tolerable for long-term migraine prevention in adults.

Summary

The 8 ongoing clinical trials for migraine with aura are predominantly concentrated in European countries, with Poland, Spain, Italy, France, and Hungary hosting the most studies. A notable focus exists on pediatric populations, with several trials specifically examining the safety and effectiveness of treatments in children and teenagers aged 6 to 17 years.

Atogepant emerges as the most frequently studied medication across these trials, appearing in 6 of the 8 studies. Researchers are evaluating it for both acute treatment and preventive purposes in various age groups and comparing it to established treatments like topiramate. Rimegepant is being investigated in 2 trials focused on pediatric patients, while amiloride represents a unique approach as it is traditionally used for high blood pressure but is being tested for preventing migraine aura in a single French study.

The trials employ various study designs, including double-blind placebo-controlled studies for initial effectiveness evaluation and open-label extensions for long-term safety assessment. Many studies examine both migraine with aura and without aura, recognizing that treatment approaches may benefit both presentations of the condition. The research spans both acute treatment of individual attacks and preventive strategies aimed at reducing attack frequency.

Ongoing Clinical Trials on Migraine with aura

  • Study on Rimegepant for Treating Acute Migraine in Children and Adolescents Aged 6 to 17 Years

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland Spain Sweden

  • Study on the Safety and Effectiveness of Atogepant for Preventing Episodic Migraine in Children and Teens Aged 6 to 17

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark France Hungary Italy The Netherlands +4

  • Study on Long-Term Safety of Atogepant for Preventing Migraine in Patients with Chronic or Episodic Migraine

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark France Germany Hungary Italy +3

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