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

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Atogepant for the treatment of Migraine. Migraines are severe headaches that can cause intense throbbing or pulsing in one area of the head and are often accompanied by nausea, vomiting, and extreme sensitivity to light and sound. The study will compare the effectiveness of Atogepant, which is taken as a tablet, to a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate how well Atogepant works in treating a single migraine attack. Participants will be randomly assigned to receive either Atogepant or a placebo. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the initial phase. This helps ensure that the results are not influenced by expectations about the treatment. After this phase, there will be an “open-label extension,” where all participants will have the opportunity to receive Atogepant.

Throughout the study, participants will take the medication when they experience a migraine attack and will be monitored for their response to the treatment. The study will assess various outcomes, such as the relief of headache pain and the ability to return to normal activities. The trial aims to provide valuable information about the safety and effectiveness of Atogepant for people who suffer from migraines.

1 randomization

Upon joining the study, you will be randomly assigned to receive either the atogepant tablet or a placebo. This process is double-blind, meaning neither you nor the researchers will know which one you are receiving.

2 treatment period

During the treatment period, you will take a single dose of the assigned tablet orally when you experience a migraine attack. The tablet is 60 mg, and it is important to take it as soon as the migraine begins.

3 monitoring and assessment

After taking the tablet, your response to the treatment will be monitored. Key assessments include pain relief and the ability to function normally at various time points, such as 2 hours and 8 hours after taking the dose.

You will be asked to record your symptoms and any side effects in an electronic diary (eDiary). This information helps evaluate the effectiveness and safety of the treatment.

4 open-label extension

Following the initial treatment period, there is an open-label extension phase. In this phase, all participants will receive the atogepant tablet, allowing further evaluation of its long-term effects.

5 completion

The study is expected to conclude by November 23, 2025. Upon completion, the collected data will be analyzed to determine the overall efficacy and safety of atogepant for treating migraine attacks.

Who Can Join the Study?

  • You must agree to participate by signing a consent form before any study procedures begin.
  • You should have a history of migraines that last between 4 to 72 hours if not treated or if treatment fails, with at least 48 hours of no headache pain between episodes.
  • You should 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.
  • If you are a female, you must not be pregnant or breastfeeding, and you should not plan to become pregnant or donate eggs during the study and for about 30 days after the last dose of the study drug.
  • If you are a female who can have children, you must have a negative pregnancy test at the first visit and another negative test at the second visit. If the test results are unclear, further testing is required, and you cannot participate if the result is positive.
  • If you are a female who can have children, you must use at least one approved method of birth control from 30 days before the second visit until 30 days after the last dose of the study drug. If you cannot have children, birth control is not needed.
  • You should have used medication, either prescribed or over-the-counter, for treating migraines in the past.
  • If you are taking oral or injectable medications to prevent migraines, the treatment must be stable for at least 3 months before the second visit and should not change during the study.
  • If you are part of the Triptan-Unsuitable substudy, you must meet all the main study criteria and not meet any exclusion criteria. You must also be considered “triptan-unsuitable,” meaning you either cannot use triptans due to medical reasons or have tried at least two different triptans without achieving pain relief.
  • You must be able and willing to read, understand, and complete study questionnaires and an electronic diary.
  • You must be between 18 to 75 years old at the first visit and meet the legal age of adulthood according to local laws.
  • You should have a history of migraines, with or without aura, for at least 12 months before the first visit.
  • Your migraines should have started before you turned 50 years old.

Who Cannot Join the Study?

  • Patients who have a history of allergic reactions to the study medication or similar medications cannot participate. An allergic reaction is when your body reacts badly to something, like a rash or trouble breathing.
  • Individuals with serious health conditions that might interfere with the study results are excluded. Serious health conditions are illnesses that can affect your overall health significantly.
  • Participants who are currently taking other medications that might interact with the study drug are not allowed. Some medications can change how other drugs work in your body.
  • Women who are pregnant or breastfeeding cannot join the study. Pregnancy and breastfeeding involve changes in the body that could affect the study.
  • People who have participated in another clinical trial recently are not eligible. This is to ensure that previous treatments do not affect the study results.
  • Individuals with a history of substance abuse are excluded. Substance abuse means using drugs or alcohol in a way that is harmful to your health.
  • Patients who have a mental health condition that might affect their ability to follow study instructions are not allowed. Mental health conditions can include things like depression or anxiety.
  • Anyone who cannot commit to attending all study visits or follow the study procedures is excluded. This is important to ensure accurate and complete study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Linden Sp. z o.o. sp.k. Cracow Poland
Nyiro Gyula Orszagos Pszichiatriai Es Addiktologiai Intezet Budapest Hungary
Neuropraxis Muenchen-Sued Unterhaching Germany
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Praglandia s.r.o. Prague Czechia
Instituto Di Ricovero E Cura A Carattere Scientifico Bologna Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital De Santa Maria E.P.E. Lisbon Portugal
University Hospital Bratislava Bratislava Slovakia
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Ambenet GmbH Das Ambulante Behandlungsnetz Leipzig Germany
Silmedic Sp. z o.o. Katowice Poland
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
Vitamed Galaj I Cichomski Sp. j. Bydgoszcz Poland
INEP medical s.r.o. Prague Czechia
Neurohk s.r.o. Chocen Czechia
Athleticomed Sp. z o.o. Bydgoszcz Poland
Hospital Clinico Universitario De Valladolid Valladolid Spain
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas Liptovsky Mikulas Slovakia
Clintrial s.r.o. Prague Czechia
Cortex Study Center Budapest Hungary
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Da Luz S.A. Lisbon Portugal
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Semmelweis University Budapest Hungary
Istituto Neurologico Mediterraneo Neuromed S.p.A. Pozzilli Italy
Jessa Ziekenhuis Hasselt Belgium
CTC Clinical Trial Consultants AB Uppsala Sweden
Vestra Clinics s.r.o. Rychnov Nad Kneznou Czechia
Klinische Forschung Berlin GbR Berlin Germany
Cliniq s.r.o. Bratislava Slovakia
Centro Hospitalar de Setubal E.P.E. Setubal Portugal
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Vrije Universiteit Brussel Jette Belgium
Universita Degli Studi Di Brescia Brescia Italy
Fakultni Thomayerova nemocnice Prague Czechia
University Hospital Ostrava Ostrava Czechia
Forbeli s.r.o. Prague Czechia
Centrum Leczenia MIGRE Wroclaw Poland
Kopfschmerzzentrum Frankfurt Frankfurt Germany
Cabinet Prive Dr. Sava Saint-Nicolas Belgium
Appr Cstvssco shoyxf Prague Czechia
Hvxdkxsbokpghieoeuij Ltsv Lier Belgium
Uwcumqcqgdgzfhrqgcris Eeizc Ald Essen Germany
Hhjcrdza Usxptwrgyzsth Medgbnt Dx Vspetgqgfy Santander Spain
Cwdnymc Bpvns Kkrzmdslvwj Pwwefzgj Skk z orho Gdansk Poland
Afsgjlm Skqisjnvc Lwxdgy Axqhannh Stcjuby Lauepkrfgshuev L'aquila Italy
Dhrv Mgpgnvh sccnvk Prague Czechia
Smdrtx sjjgsx Presov Slovakia
Mdrvw Bdhmn Dgutears nawxjjudusgs auvzzveybf sstmrt Banska Bystrica Slovakia
Ckdr De Cieu Azdxxutvnpb Ixczazie Caqhyecwma Ofmlhdfkeh Tarpknthrbheuw Mjolp Ppaiysdx Latina Italy
Sikbrfi Cnwgizi Mhjpasrv Svi z oijr Poznan Poland
Sstwrnzr Aj Lund Sweden
Aaglylt Sburpwbajpopwo Lhtkno 2 Savona Italy
Uaghsvntfyq nmtocdcaz &tetwki Nwrbphnbb shjhzhm Mnuggxmg ax s Bratislava Slovakia
Asyceyi Oozmktuvbrc Uszrgufenkdip Ctvngpmovgyk Dacqh Sornez E Donjo Ssprmdc Dh Toxaiz Turin Italy
Uotuqnfoxy Ok Afynhks Edegem Belgium
Ffjkzawhv Pqdn Lf Igqvadawtwssq Bustxlpyo Ded Hdxscbzk Uyqjokgauezjy Lv Prl Madrid Spain
Hawzptyw Vamb dhsphoit Barcelona Spain
Svagfrowp Kvsa Budapest Hungary
Iohhsvyi Zwrbeak Dp Bohocjfaotkpbrtne Oświęcim Poland
Uoh Mwiovgq Tourak Kobh Budapest Hungary
Ilewn Oybfargo Aohhggognm Sxa Lpmi Milan Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.04.2024
Czechia Czechia
Not recruiting
01.04.2024
Germany Germany
Not recruiting
01.04.2024
Hungary Hungary
Not recruiting
01.04.2024
Italy Italy
Not recruiting
01.04.2024
Poland Poland
Not recruiting
01.04.2024
Portugal Portugal
Not recruiting
01.04.2024
Slovakia Slovakia
Not recruiting
01.04.2024
Spain Spain
Not recruiting
01.04.2024
Sweden Sweden
Not recruiting
01.04.2024

Trial locations

Investigated drugs:

Atogepant is a medication being studied for its effectiveness in treating migraine attacks. It is taken as a single dose to see how well it can relieve the symptoms of a migraine. The trial aims to determine if atogepant can effectively treat a migraine attack compared to not taking any active medication.

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often on one side of the head. These headaches can be accompanied by 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 exact cause of migraines is not fully understood, but they are believed to involve genetic and environmental factors. Triggers can include stress, certain foods, hormonal changes, and sensory stimuli.

Trial ID:
2023-506029-12-00
Protocol code:
M24-305
NCT ID:
NCT06241313
Trial Phase:
Therapeutic confirmatory (Phase III)

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