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Ongoing Clinical Trials for Migraine Without Aura

This article provides information about 10 ongoing clinical trials focused on migraine without aura. These trials are testing various medications including atogepant, rimegepant, cilostazol, sildenafil, and high-flow oxygen therapy. The studies are being conducted across multiple European countries including Germany, Poland, Spain, Italy, France, Denmark, Sweden, Belgium, Netherlands, Hungary, Slovakia, Czechia, Portugal, Romania, and Austria. Trials involve adults, children, and adolescents, with goals ranging from acute treatment to long-term prevention of migraine attacks.

Clinical trial locations

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

This clinical trial investigates atogepant, an oral tablet medication designed to treat individual migraine attacks. The study compares atogepant to a placebo in a double-blind design, meaning neither participants nor researchers know who receives the active medication during the initial phase. After this period, all participants can receive atogepant in an open-label extension.

Main inclusion criteria: Participants must be adults aged 18 to 75 years with a documented history of migraines lasting 4 to 72 hours when untreated. They should experience 2 to 8 moderate to severe migraine attacks per month over the three months before enrollment, with at least 48 hours pain-free between episodes. Women of childbearing potential must use effective contraception and have negative pregnancy tests. Previous use of migraine medication is required, and any preventive medications must remain stable for at least three months before and during the study.

Main exclusion criteria: The study excludes individuals with allergic reactions to atogepant or similar medications, serious health conditions that could interfere with results, current use of interacting medications, pregnancy or breastfeeding, recent participation in other trials, history of substance abuse, and mental health conditions that might affect adherence to study instructions.

Trial focus: The primary goal is to evaluate how effectively atogepant relieves headache pain and other migraine symptoms, allowing participants to return to normal activities. Researchers will monitor pain relief at various time points, particularly at 2 and 8 hours after taking the medication.

Investigational drug: Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist that blocks proteins involved in migraine development. It is taken as a single 60 mg oral dose at the onset of a migraine attack.

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

This trial examines the long-term safety of atogepant for preventing migraines in children and adolescents aged 6 to 17 years. The study focuses on monitoring potential side effects over an extended period rather than testing effectiveness.

Main inclusion criteria: Participants must be between 6 and 17 years old with a documented history of episodic or chronic migraines for at least six months. They must have completed certain visits in previous related studies without significant problems, weigh at least 20 kg (44 lbs) but less than 135 kg (298 lbs), and be able to complete questionnaires with parental help if needed.

Main exclusion criteria: The study excludes children outside the specified age range, those unable to follow study procedures, individuals with serious health conditions that might interfere with participation, those with allergies to the study medication, pregnant or breastfeeding participants, and those with a history of substance abuse or uncontrolled psychiatric disorders.

Trial focus: The study monitors participants for adverse events, checking laboratory results, heart function through electrocardiograms, vital signs including blood pressure and heart rate, and any behavioral or mood changes. Special attention is given to menstrual cycle changes in applicable participants.

Investigational drug: Atogepant works by blocking CGRP receptors in the brain, reducing the frequency and severity of migraine attacks. The medication is taken regularly in tablet form to prevent migraines rather than treat active attacks.

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

This clinical trial tests rimegepant, an oral lyophilisate (dissolving tablet), for treating individual migraine attacks in young people aged 6 to 17 years. The study compares rimegepant with placebo to determine its effectiveness in providing pain relief.

Main inclusion criteria: Participants must be between 6 and 18 years old, weighing more than 40 kg (or more than 15 kg for younger children), with a history of migraines lasting more than six months. They should experience 1 to 8 moderate or severe migraine attacks per month in the two months before joining, with attacks lasting more than three hours without treatment. Participants must be able to distinguish migraines from other headache types. If taking preventive medications, dosages must remain stable for at least 12 weeks before and during the study. Female participants who have started menstruating and sexually active males must use effective contraception.

Main exclusion criteria: The study excludes individuals with allergic reactions to rimegepant or similar medications, those taking medications that might interfere with the study drug, people with certain medical conditions making participation unsafe, pregnant or breastfeeding individuals, recent participants in other trials, and those unable to follow study procedures.

Trial focus: The primary goal is to assess whether participants achieve freedom from pain within two hours of taking rimegepant and whether they experience relief from bothersome symptoms like nausea, sensitivity to light, and sensitivity to sound. The study also monitors the need for additional pain medication and evaluates sustained pain relief over time.

Investigational drug: Rimegepant is a CGRP receptor antagonist taken as an oral lyophilisate in dosages of either 25 mg or 75 mg, designed to block pain transmission proteins involved in migraine development.

Study on the Effectiveness of High-Flow Oxygen Therapy for Migraine Attacks in Emergency Department Patients

This trial investigates whether high-flow oxygen therapy can effectively reduce migraine pain intensity in emergency department settings. The study compares inhaled oxygen to placebo air in patients experiencing acute migraine attacks.

Main inclusion criteria: Participants must be at least 18 years old, admitted to the emergency department with a headache meeting International Classification of Headaches criteria for migraine, have pain intensity of at least 6 on a 0-10 scale, and provide written informed consent.

Main exclusion criteria: The study excludes patients not experiencing a migraine, those under 18 or over 65 years old, and individuals from vulnerable populations requiring special protection.

Trial focus: The primary outcome measures pain levels 30 minutes after starting oxygen therapy, aiming for pain scores of 3 or less on the 0-10 scale. The study also monitors associated symptoms like nausea and light sensitivity at 0, 30, 60, and 90 minutes, tracks pain recurrence, records side effects, documents emergency painkiller use, and measures time spent in the emergency department.

Investigational treatment: High-flow oxygen therapy delivers compressed medicinal oxygen at higher rates than normal breathing through specialized equipment. The treatment session lasts 30 minutes and aims to increase brain oxygen levels to alleviate migraine symptoms.

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

This open-label trial evaluates the long-term safety and tolerability of rimegepant for treating acute migraine attacks in children and adolescents aged 6 to 18 years. Unlike blinded studies, both participants and researchers know which medication is being administered.

Main inclusion criteria: Participants must be between 6 and 18 years old, weighing more than 40 kg (or more than 15 kg for younger children), with a history of migraines lasting more than six months. They should experience 1 to 8 moderate or severe attacks per month and must have experienced at least one migraine day requiring treatment during the study observation phase. Participants must be able to distinguish migraines from other headaches. Preventive medication dosages must remain stable for at least 12 weeks before and during the study. Female participants who have started menstruating and sexually active males must use effective contraception and have negative pregnancy tests.

Main exclusion criteria: The study excludes individuals outside the specified age range, those with medical conditions other than acute migraine, people unable to follow study procedures, recent participants in other trials, those with allergies to rimegepant or similar medications, individuals with interfering health problems, pregnant or breastfeeding participants, and those taking medications that might interact with rimegepant.

Trial focus: The study monitors the frequency and severity of adverse events over an extended period, identifies clinically significant laboratory abnormalities through regular blood tests, and assesses overall safety and tolerability of long-term use.

Investigational drug: Rimegepant is administered as an oral lyophilisate in 25 mg or 75 mg dosages. It works by blocking CGRP receptors involved in migraine headache development, taken as needed when migraine attacks occur.

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

This double-blind trial tests two different doses of atogepant against placebo for preventing episodic migraines in children and teenagers aged 6 to 17 years. Episodic migraine means headaches occurring on fewer than 15 days per month.

Main inclusion criteria: Participants must weigh between 20 kg (44 lbs) and 135 kg (298 lbs), have a history of episodic migraine for at least six months, and have experienced 4 to 14 migraine days with fewer than 15 total headache days in the 28 days before enrollment, as recorded in an electronic diary. For the pharmacokinetic substudy, participants must be 6 to 11 years old with a migraine history and doctor-approved suitability for preventive treatment.

Main exclusion criteria: The study excludes individuals with allergic reactions to atogepant or similar medications, those taking medications that might interfere with the study drug, people with serious health conditions affecting safety, recent participants in other trials within 30 days, pregnant or breastfeeding individuals, those with substance abuse history, and people with mental health conditions interfering with study instruction compliance.

Trial focus: The primary goal is to assess the reduction in migraine and headache days over a 12-week treatment period. The study evaluates changes in monthly migraine frequency, acute medication use, and quality of life scores through regular monitoring and electronic diary entries.

Investigational drug: Atogepant is taken orally once daily in tablet form at either low dose (10 mg) or high dose (60 mg). It works by blocking CGRP receptors in the brain to prevent migraine development and reduce attack frequency.

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

This trial investigates how cilostazol affects men and women with migraines differently. Cilostazol increases levels of a substance called cAMP in the body, which researchers believe may be involved in migraine development.

Main inclusion criteria: Participants must be healthy men and women aged 18 to 65 years, weighing between 50 and 100 kg, with a diagnosis of episodic migraine without aura according to International Classification criteria. Migraines must have occurred for at least 12 months before joining and started before age 50. Women must use safe contraception throughout the study, and participants must be fluent in Danish or English.

Main exclusion criteria: The study excludes individuals outside the specified age range, pregnant or breastfeeding women, those with heart disease history, stroke survivors, people with uncontrolled high blood pressure, those taking medications affecting blood flow, individuals with severe liver or kidney problems, people with severe allergic reaction history, and recent participants in other trials within 30 days.

Trial focus: The study observes differences in migraine-like attack occurrence between those taking cilostazol and those taking placebo, monitors differences in heart rate and blood pressure especially within the first 90 minutes, and tracks side effects during the observation period lasting up to 12 hours after taking the medication.

Investigational drug: Cilostazol is taken as a single 100 mg oral tablet. It works as a phosphodiesterase inhibitor, blocking an enzyme that breaks down cAMP, thereby increasing cAMP levels in cells and helping relax blood vessels.

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

This trial compares the safety and effectiveness of atogepant with topiramate, an established preventive medication, for preventing migraines in adults. The study includes a double-blind treatment period followed by an open-label extension.

Main inclusion criteria: Participants must have a documented history of migraine with or without aura for at least 12 months before enrollment, experience at least 4 migraine days per month requiring preventive treatment, and be eligible regardless of gender or vulnerable population status.

Main exclusion criteria: The study excludes individuals unable to follow study instructions or procedures, those with severe allergic reactions to study medications, people who used other migraine prevention treatments recently, those with certain interfering medical conditions, pregnant or breastfeeding women, current participants in other trials, people with drug or alcohol abuse history, those who had recent surgery or plan surgery during the study, individuals with uncontrolled high blood pressure, and people with certain heart conditions affecting study safety.

Trial focus: The primary outcome measures treatment discontinuation due to adverse events during the 24-week double-blind period. Secondary outcomes include reduction in average monthly migraine days during months 4 to 6, changes in headache impact scores at week 24, and quality of life improvements.

Investigational drugs: Atogepant is taken orally once daily and works by blocking CGRP receptors involved in migraine development. Topiramate is also taken orally and works by stabilizing electrical activity in the brain. The study evaluates how well participants tolerate the highest dose they can handle of each medication.

Study on Headache Effects of Sildenafil and Placebo in Men and Women with Episodic Migraine Without Aura

This trial investigates how sildenafil, a medication commonly used for other conditions, influences headache and migraine-like attack occurrence in men and women with episodic migraines. The study compares sildenafil effects with placebo.

Main inclusion criteria: Participants must be healthy men and women aged 18 to 50 years, weighing between 60 and 90 kg, with a diagnosis of migraine without aura. They should have experienced one to six migraine attacks in the last eight weeks, be fluent in Danish or English, and women must use safe contraception including hormonal therapies, intrauterine devices, or oral pills.

Main exclusion criteria: The study excludes individuals without migraine without aura diagnosis, those outside the specified age range, and vulnerable populations requiring special protection.

Trial focus: The study observes differences in headache and migraine-like attack occurrence between sildenafil and placebo groups, monitors heart rate and mean arterial pressure differences between treatments, and records adverse event incidence to ensure participant safety.

Investigational drug: Sildenafil is administered as a single 100 mg film-coated tablet taken orally. It works as a phosphodiesterase type 5 (PDE5) inhibitor, increasing blood flow by blocking an enzyme. While commonly used for erectile dysfunction and pulmonary hypertension, this study examines its role in potentially inducing migraine symptoms.

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

This open-label trial evaluates the long-term safety and tolerability of atogepant for preventing migraines over 156 weeks (approximately three years) in patients with chronic or episodic migraines.

Main inclusion criteria: Participants must have completed specific visits from previous related studies without significant protocol violations or serious adverse events, be diagnosed with chronic or episodic migraine with or without aura, and be eligible regardless of gender or vulnerable population status.

Main exclusion criteria: The study excludes individuals with other serious health conditions interfering with participation, current participants in other trials, pregnant or breastfeeding women, those who had recent surgery or plan surgery during the study, people with drug or alcohol abuse history in the past year, individuals with allergies to atogepant or similar drugs, those unable to comply with study procedures or follow-up visits, anyone with uncontrolled mental health disorders, and individuals who used certain interfering medications within a specified timeframe before the study.

Trial focus: The study monitors treatment-emergent adverse events throughout the 156-week period, assesses clinically significant laboratory value changes through regular testing, evaluates heart function using electrocardiograms, and tracks vital sign changes including blood pressure and heart rate.

Investigational drug: Atogepant is taken orally once daily as a 60 mg tablet. It works by blocking CGRP receptors in the brain, helping reduce migraine frequency. The extended study duration allows researchers to gather comprehensive data on long-term safety and tolerability.

Summary

These 10 clinical trials represent diverse approaches to managing migraines in various patient populations. Several notable patterns emerge from the data. Atogepant appears most frequently, being studied in six trials across different age groups and for both acute treatment and prevention. Poland hosts the most trials with seven studies, followed by Spain, Italy, France, and Hungary with six each, indicating strong European research infrastructure for migraine studies.

The trials address different patient needs: some focus on acute attack treatment while others examine long-term prevention. Pediatric populations receive significant attention, with four trials specifically studying children and adolescents aged 6 to 17 years. These trials test both atogepant and rimegepant, representing newer CGRP receptor antagonist medications.

Methodological approaches vary, including double-blind placebo-controlled studies for efficacy testing and open-label extensions for long-term safety monitoring. Two trials investigate unique approaches: high-flow oxygen therapy in emergency departments and experimental use of medications like cilostazol and sildenafil to better understand migraine mechanisms.

The geographical distribution shows concentration in Western and Central European countries, with multiple trials often running simultaneously in the same nations, suggesting coordinated research efforts and established clinical trial networks. This geographical pattern may reflect healthcare system capabilities, regulatory frameworks, and patient recruitment infrastructure rather than disease prevalence patterns.

Ongoing Clinical Trials on Migraine without aura

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

    Recruiting

    1 1 1
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    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 of the effects of pitolisant on migraine without aura in women

    Not yet recruiting

    1 1
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    Investigated drugs:
    Denmark

  • Study on Headache Effects of Sildenafil and Placebo in Men and Women with Episodic Migraine Without Aura

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • 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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