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Migraine – Trials in Disease

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Clinical Trials for Migraine: Ongoing Research and Treatment Options

There are currently 43 clinical trials studying various treatments for migraine, ranging from preventive medications to acute relief options. These studies are investigating both established and novel therapies for people experiencing episodic and chronic migraine, including specialized trials for children, adolescents, and specific populations such as women with menstrual-related migraines.

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

This trial is comparing four commonly used medications for preventing migraines in people receiving care from their primary doctors. The medications being tested include amitriptyline, flunarizine, topiramate, and propranolol, each working through different mechanisms to reduce migraine frequency.

Main inclusion criteria: Adults (at least 18 years old) who need preventive migraine treatment and experience at least 4 migraine days per month. Both men and women can participate.

Main exclusion criteria: People with medical conditions other than migraine that could interfere with the study, those currently taking medications that might affect study results, those with a history of allergic reactions to the study medications, pregnant or breastfeeding women, recent participation in another clinical trial, history of substance abuse, significant psychiatric disorders that are not well controlled, and inability to comply with study procedures or follow-up visits.

Focus and goal: The main goal is to evaluate how well these medications reduce the number of migraine days each month over a 12-week period. Participants will take their assigned medication daily and keep track of their migraine symptoms and any side effects. Researchers hope to determine which medication is most effective in preventing migraines in primary care settings.

Investigational drugs: The study tests four medications: Amitriptyline, which increases neurotransmitter levels in the brain; Flunarizine, which blocks calcium channels to prevent blood vessel constriction; Topiramate, which stabilizes electrical activity in the brain; and Propranolol, a beta-blocker that relaxes blood vessels and improves blood flow.

Study of Eptinezumab Given Intravenously for Prevention of Chronic Migraine in Adolescents Aged 12-17 Years

This study focuses on young people aged 12 to 17 who have chronic migraine. It evaluates eptinezumab, a medication given through intravenous infusion, to determine if it can reduce the number of days that young patients experience migraines.

Main inclusion criteria: Participants must be between 12 and 17 years old, have a migraine diagnosis for at least 6 months, and experience headaches on 15-26 days per month with at least 8 being migraine days. For EU countries and India, participants must weigh more than 40 kilograms.

Main exclusion criteria: History of any chronic pain condition other than migraine, previous diagnosis of medication overuse headache, current use of other preventive migraine medications, presence of severe uncontrolled psychiatric conditions, history of stroke or serious brain conditions, pregnant or breastfeeding women, active liver disease, history of allergic reactions to similar medications, certain medications that might interact with the study drug, participation in another clinical trial within the past 30 days, uncontrolled high blood pressure, history of substance abuse, serious heart conditions, and inability to follow study procedures.

Focus and goal: The study monitors participants for 12 weeks while they continue using an electronic diary to record their migraine days. Researchers will track changes in migraine frequency and the use of other migraine medications, assessing the treatment’s impact on daily activities through the PedMIDAS questionnaire.

Investigational drug: Eptinezumab is a humanized monoclonal antibody that works by blocking calcitonin gene-related peptide (CGRP), a protein involved in migraine development.

Study of IncobotulinumtoxinA injections compared to placebo for prevention of episodic migraine attacks

This trial studies whether Xeomin (incobotulinumtoxinA) injections are effective in preventing episodic migraine, a condition where headaches occur between 6 to 14 days per month.

Main inclusion criteria: Participants must be aged 18 to 65 years, have experienced 6-14 migraine days per month for the past 3 months, and have had their first migraine before age 50. They must maintain records in a headache diary for at least 28 days.

Main exclusion criteria: History of chronic migraine (15 or more headache days per month), current use of preventive migraine medications, previous botulinum toxin treatment in the past 6 months, presence of other types of headaches that could interfere with migraine assessment, pregnancy or breastfeeding, known allergic reactions to botulinum toxin products, active neurological conditions, history of neuromuscular junction disorders, use of medications that could interact with the study treatment, participation in another clinical trial within the past 30 days, severe psychiatric disorders, uncontrolled medical conditions, history of substance abuse within the past year, and inability to follow study procedures.

Focus and goal: The study will last 6 months with participants receiving multiple injection sessions. Researchers will monitor changes in monthly migraine days and headache days every four weeks during specific assessment periods to determine effectiveness.

Investigational drug: Xeomin contains botulinum toxin type A, which works by temporarily blocking nerve signals that cause muscle contractions and may help block pain signals, reducing the frequency and severity of migraine headaches through targeted injections in the head and neck area.

Study of incobotulinumtoxinA injections for prevention of chronic migraine in adult patients

This clinical trial investigates the use of Xeomin (botulinum toxin type A) injections for people with chronic migraine, defined as experiencing headaches on 15 or more days per month with at least 8 being migraine headaches.

Main inclusion criteria: Participants must be at least 18 years old, have been diagnosed with chronic migraine for more than 12 months, and have experienced their first migraine before age 50. They must have at least 15 headache days per month and at least 8 migraine days per month, documented through an electronic diary for at least 22 valid days during the 4 weeks before starting the study.

Main exclusion criteria: Age below 18 or above 65 years, currently pregnant or breastfeeding women, history of botulinum toxin treatment in the past 6 months, known allergies or hypersensitivity to botulinum toxin or study medication components, current use of medications that could interact with botulinum toxin, presence of neuromuscular junction disorders, active infection at potential injection sites, history of facial surgery that could affect study results, participation in another clinical trial within the past 30 days, any medical condition that could interfere with medication evaluation, inability to follow study procedures or attend scheduled visits, history of drug or alcohol abuse within the past year, and mental conditions that could affect the ability to provide informed consent.

Focus and goal: The study monitors participants over 24 weeks (6 months) with injections administered in treatment cycles. The primary goal is to assess changes in monthly migraine days and monthly headache days, particularly during weeks 21-24 after the first injection. Success is determined by at least a 50% reduction in monthly migraine days.

Investigational drug: Xeomin contains botulinum toxin type A, administered through intramuscular injections at specific points around the head and neck. It works by temporarily blocking nerve signals that trigger muscle contractions and pain pathways, inhibiting the release of acetylcholine at nerve endings, which helps reduce muscle tension and neurogenic inflammation associated with chronic migraines.

Study of rimegepant for preventing chronic migraine in adolescents aged 12 to 17 years

This study focuses on preventing chronic migraine in young people aged 12 to under 18 years using rimegepant sulfate, an orodispersible tablet that dissolves in the mouth.

Main inclusion criteria: Participants must have had migraines for at least 6 months, experience 15 or more headache days per month in the 3 months before screening with 8 or more being migraine days, be able to tell the difference between migraine attacks and other types of headaches, and typical migraine attacks must last between 4 and 72 hours when not treated. Both participant and parent/legal guardian must sign required consent forms.

Main exclusion criteria: History of any chronic pain condition other than migraine (lasting more than 3 months), previous diagnosis of medication overuse headache, current use of other preventive migraine medications, presence of severe psychiatric conditions that are not well controlled, history of stroke or other serious brain conditions, pregnant or breastfeeding women, active liver disease or abnormal liver function tests, history of allergic reactions to similar medications, use of certain medications that might interact with the study drug, participation in another clinical trial within the past 30 days, uncontrolled high blood pressure, history of substance abuse within the past year, serious heart conditions or abnormal heart rhythm, inability to follow study procedures or complete headache diary, and any condition that makes participation unsafe.

Focus and goal: The study includes an initial observation phase to document migraine patterns, followed by a 12-week double-blind treatment phase where participants are randomly assigned to receive either rimegepant sulfate or placebo. The primary goal is to observe a reduction in the number of migraine days per month. Throughout the study, participants track their headache days, migraine days, and medication use in an electronic diary and complete quality of life questionnaires.

Investigational drug: Rimegepant is a CGRP receptor antagonist that works by blocking specific proteins in the brain involved in causing migraine pain. It is administered orally in tablet form and represents a targeted approach to migraine prevention, currently being evaluated in Phase 3 clinical trials for adolescent populations aged 12 to 18 years who experience chronic migraines.

Study on Atogepant for Preventing Menstrual Migraine in Women

This clinical trial studies atogepant for preventing menstrual migraine, a type of headache that occurs in connection with a woman’s menstrual cycle. The medication is taken for seven consecutive days to see if it can reduce migraine days during the perimenstrual period.

Main inclusion criteria: Adult participants who are at least 18 years old, with regular menstrual cycles lasting between 21 to 35 days. Participants must have a history of migraine for at least 12 months, with the first migraine starting before age 50. They must meet criteria for pure menstrual migraine or menstrually-related migraine, experiencing migraine attacks starting from two days before to three days after menstruation onset in at least 2 out of 3 menstrual cycles. During screening, participants must record 3 perimenstrual periods in an electronic diary with at least one migraine day in at least 2 out of 3 periods.

Main exclusion criteria: Any other type of headache disorder besides menstrual migraine, pregnancy or plans to become pregnant during the study, breastfeeding, serious medical conditions that could interfere with the study, history of drug or alcohol abuse, taking medications that could interfere with the study treatment, participation in another clinical trial within the last 30 days, and known allergies to the study medication.

Focus and goal: The study is designed as double-blind, meaning neither participants nor researchers know who receives the actual medication or placebo. The main goal is to assess the change in the number of migraine days during the perimenstrual period over three menstrual cycles. Secondary evaluations include reduction in migraine days, use of acute medication, and level of disability or impairment experienced. The study is expected to conclude by August 2027.

Investigational drug: Atogepant is administered orally in tablet form and is being studied in Phase 3 trials for preventing menstrual migraines. It works by blocking the calcitonin gene-related peptide (CGRP) receptor, which is involved in the development of migraine headaches, and is classified pharmacologically as a CGRP receptor antagonist.

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

This clinical trial studies atogepant for treating single migraine attacks, comparing its effectiveness with a placebo to evaluate how well it provides pain relief and helps patients return to normal activities.

Main inclusion criteria: Participants must sign a consent form before any study procedures begin, have a history of migraines lasting between 4 to 72 hours if not treated with at least 48 hours of no headache pain between episodes, and have experienced 2 to 8 migraine attacks per month with moderate to severe pain in each of the 3 months before the first study visit. For females of childbearing potential, requirements include not being pregnant or breastfeeding, having negative pregnancy tests at screening visits, and using at least one approved method of birth control. Participants should have used medication for treating migraines in the past, and if taking oral or injectable preventive medications, the treatment must be stable for at least 3 months. Age must be between 18 to 75 years old with a migraine history for at least 12 months, starting before age 50.

Main exclusion criteria: History of allergic reactions to the study medication or similar medications, serious health conditions that might interfere with the study, current medications that might affect study results, pregnancy or breastfeeding, recent participation in another clinical trial, history of substance abuse, mental health conditions that could affect study participation, and inability to comply with study procedures or follow study instructions.

Focus and goal: The study is double-blind during the initial phase, with participants taking a single oral dose when experiencing a migraine attack. Researchers monitor response at various time points, such as 2 hours and 8 hours after taking the dose, evaluating pain relief and ability to function normally. Participants record their symptoms and any side effects in an electronic diary. An open-label extension phase follows, where all participants receive atogepant, allowing further evaluation of long-term effects. The study concludes by November 23, 2025.

Investigational drug: Atogepant is administered orally in tablet form and is currently being studied for the acute treatment of migraine attacks. It works by blocking the activity of calcitonin gene-related peptide (CGRP), a protein involved in migraine development, potentially reducing the frequency and severity of migraine attacks. It is classified pharmacologically as a CGRP receptor antagonist.

Study on Atorvastatin for Preventing Chronic Migraine in Adults

This clinical trial studies atorvastatin for preventing chronic migraine, building on positive results from smaller studies for episodic migraines. The study aims to determine if atorvastatin can help prevent chronic migraines in a larger group of participants.

Main inclusion criteria: Age between 18 and 65 years, signed informed consent, chronic migraine diagnosis according to ICHD-3 criteria, at least 15 headache days per month with at least 8 migraine days confirmed in a headache diary at baseline, having started migraines at least one year prior to inclusion and before age 50, no use of other migraine preventive medications during the study, and for women of child-bearing potential, no pregnancy or planned pregnancy with use of highly effective birth control.

Main exclusion criteria: Patients who do not have chronic migraine, those not within the specified age range, and patients who are part of a vulnerable population.

Focus and goal: The study will last for 12 months, during which participants take one tablet daily (either atorvastatin 40 mg or placebo). Throughout the study, participants maintain a headache diary to track migraine and headache days. The goal is to compare the number of migraine days experienced by those taking atorvastatin with those taking placebo, while monitoring side effects and evaluating overall cost-effectiveness of the treatment.

Investigational drug: Atorvastatin is a statin medication taken orally in tablet form. While primarily known for lowering cholesterol levels, it is being studied for its potential to prevent chronic migraines. It works by inhibiting an enzyme involved in cholesterol production, which may also influence blood vessels and inflammation that could help in migraine prevention.

Study on Atorvastatin for Preventing Episodic Migraine in Adults

This clinical trial studies atorvastatin for preventing episodic migraine, testing two different doses (20 mg and 40 mg) compared to placebo to confirm whether positive effects observed in smaller studies can be replicated in a larger group.

Main inclusion criteria: Aged 18 to 65 years with 4-14 migraine days per month, signed informed consent, episodic migraine with or without aura according to ICHD-3 criteria, debut of migraine at least one year prior to inclusion starting before age 50 years, no use of other migraine preventive medications during the study, and for women of child-bearing potential, no pregnancy or planned pregnancy with use of highly effective contraception.

Main exclusion criteria: Patients who do not have migraine, those under 18 years old, participants who have participated in another clinical trial within the last 30 days, patients with a history of allergic reactions to Atorvastatin or similar medications, those with severe liver disease, patients with uncontrolled high blood pressure, those with a history of drug or alcohol abuse within the last year, and patients with any other medical condition that the study doctors think might make it unsafe for them to participate.

Focus and goal: The study will last up to 12 months, with participants taking medication daily. An initial assessment establishes a baseline for migraine frequency. Throughout the study, participants maintain a diary of their migraine days and headaches. The main focus is on observing changes in the number of migraine days over a four-week period, comparing those taking atorvastatin to those taking placebo. The study also examines the number of headache days and the number of participants who experience a significant reduction in migraine days.

Investigational drug: Atorvastatin is administered orally in film-coated tablet form at doses of either 20 mg or 40 mg. It is currently being studied for its potential to prevent episodic migraines. While already well-known for lowering cholesterol levels, it works by inhibiting an enzyme in the liver responsible for producing cholesterol, which may also have effects on blood vessels and inflammation that could help in reducing migraine frequency. It is classified pharmacologically as a statin.

Study on Botulinum Toxin Type A for Preventing Chronic Migraine in Adults

This clinical trial studies Dysport (Botulinum Toxin Type A) for preventing chronic migraine in adults, evaluating its effectiveness and safety in reducing monthly migraine days.

Main inclusion criteria: Participant must be at least 18 years old when signing informed consent and privacy/data protection documents, have been diagnosed with chronic migraine for more than 12 months before the screening visit, have started experiencing migraines before age 50, and have at least 15 headache days per month with at least 8 migraine days per month documented in an electronic diary during the 4 weeks before starting the study, with at least 22 valid diary days recorded.

Main exclusion criteria: Participants who do not have chronic migraine (defined as headaches on 15 or more days each month with at least 8 being migraines), those not adults, those not within the specified age range, and those who are part of a vulnerable population.

Focus and goal: The study randomly assigns participants to receive either Dysport or a placebo through intramuscular injections. Initial assessments establish baseline data including monthly migraine days (MMD) and monthly headache days (MHD). The treatment phase involves injections of either Botulinum Toxin Type A (300 or 500 units) or placebo at specified intervals. Participants are monitored for changes in MMD and MHD every four weeks from Week 4 to Week 24, with additional assessments including use of acute migraine medication and any treatment-emergent adverse events. The study may include an extension phase for further long-term evaluation.

Investigational drug: Dysport is administered through injections given by a healthcare professional. It works by blocking the release of certain chemicals in the nervous system involved in muscle contraction, which may help in reducing migraine frequency. It is classified pharmacologically as a botulinum toxin type A product and is currently being studied for its effectiveness in preventing episodic migraines in adults.

Study on Eptinezumab for Preventing Episodic Migraine in Children Aged 6-17

This clinical trial studies eptinezumab (also known as ALD403) for preventing episodic migraine in children and teenagers aged 6 to 17 years, administering the medication through intravenous infusion.

Main inclusion criteria: Participants must have a diagnosis of migraine (with or without aura) with a history of migraine headaches for at least 6 months before the screening visit. During the 28-day screening period, participants must complete a headache eDiary for at least 23 out of 28 days and have 14 or fewer headache days with at least 4 being migraine days as recorded in the eDiary. The study is open to both male and female participants.

Main exclusion criteria: History of any other type of headache disorder besides migraine, recent infection or illness that could affect study results, current use of medications that might interfere with the study treatment, known allergy or sensitivity to the study medication or similar drugs, significant medical condition that could make participation unsafe, pregnancy or breastfeeding, recent participation in another clinical trial, history of drug or alcohol abuse, and inability to comply with study procedures or follow-up visits.

Focus and goal: During the observation period, participants document their migraine patterns using the electronic diary. An intravenous administration of eptinezumab (VYEPTI 100 mg concentrate for solution for infusion) is given during the treatment phase. The primary goal is to observe changes from baseline in the number of monthly migraine days over weeks 1 to 12. Secondary observations include the percentage of participants with migraine on the day after dosing, changes in monthly headache days, and changes in the Pediatric Migraine Disability Assessment score. The study is estimated to conclude by April 13, 2026.

Investigational drug: Eptinezumab is administered intravenously and is currently being studied for its effectiveness in preventing episodic migraines in children and adolescents aged 6 to 17 years. It works by targeting and inhibiting the activity of calcitonin gene-related peptide (CGRP), a protein involved in the development of migraine headaches. It is classified as a monoclonal antibody within the pharmacological category.

Summary

The 43 ongoing clinical trials for migraine demonstrate a diverse and comprehensive approach to addressing this neurological condition across different age groups and migraine types. Several notable patterns emerge from this research landscape.

Geographic distribution: The trials show significant concentration in European countries, with Spain, Italy, Poland, Germany, and France appearing most frequently as trial locations. This European focus suggests strong research infrastructure and regulatory frameworks supporting migraine research in these regions. Denmark, Netherlands, and several Eastern European countries including Czechia, Slovakia, Hungary, and Romania also participate actively in migraine trials.

Treatment approaches: The studies examine multiple therapeutic strategies, including preventive treatments (such as CGRP antibodies, botulinum toxin injections, and oral medications) and acute treatments for migraine attacks. Notably, several trials focus on CGRP-pathway targeting medications, including eptinezumab, rimegepant, galcanezumab, and atogepant, representing newer generation therapies. Traditional approaches like botulinum toxin type A injections and established oral medications (amitriptyline, topiramate, propranolol) are also being studied.

Pediatric and adolescent focus: A significant number of trials specifically target younger populations aged 6-17 years, addressing an important gap in migraine treatment research for children and adolescents. These studies evaluate both safety and effectiveness of various treatments adapted for younger patients.

Specialized populations: Several trials focus on specific patient groups, including women with menstrual-related migraines, patients who have not responded to previous treatments, those unable to use triptan medications, and individuals with medication overuse headache.

This comprehensive research effort reflects the medical community’s commitment to developing better treatment options for the millions of people affected by migraine worldwide.

Ongoing Clinical Trials on Migraine

  • Study on Atorvastatin for Preventing Episodic Migraine in Adults

    Recruiting

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    Norway

  • Long-term safety study of eptinezumab given by intravenous infusion for children and adolescents aged 6-17 years with chronic or episodic migraine

    Recruiting

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    Italy Poland Portugal Spain

  • Study on the Effects of Cilostazol on Headaches in Men and Women with Migraine Without Aura

    Recruiting

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    Denmark

  • Study on Eptinezumab for Migraine: Understanding How It Works and Finding Patient Response Markers for Migraine Sufferers

    Recruiting

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    Italy

  • Study on Rimegepant for Preventing Migraines in Children and Teens Aged 6 to 17

    Recruiting

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    France Italy Poland Spain

  • Study of Eptinezumab Given Intravenously for Prevention of Chronic Migraine in Adolescents Aged 12-17 Years

    Recruiting

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    Italy Poland Portugal Spain

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

    Recruiting

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    Poland Spain Sweden

  • Study on Eptinezumab for Preventing Episodic Migraine in Children Aged 6-17

    Recruiting

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    Italy Poland Portugal Spain

  • A study to evaluate the effect of rimegepant in patients with migraine and obesity

    Not yet recruiting

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    Austria

  • Study on Atorvastatin for Preventing Episodic Migraine in Adults

    Not yet recruiting

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    Norway

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