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

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of two medications, Atogepant and Topiramate, for the preventive treatment of migraine. Migraines are severe headaches that can cause intense throbbing or pulsing sensations, often accompanied by nausea, vomiting, and sensitivity to light and sound. The purpose of the study is to compare how well these medications work and how safe they are for people who need to prevent migraines.

Participants in the study will be randomly assigned to receive either Atogepant, Topiramate, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drugs. The study will last for several weeks, during which participants will take the assigned medication and report any side effects or changes in their migraine symptoms. The study aims to find out if Atogepant is as effective and safe as Topiramate, which is already used for migraine prevention.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their migraine patterns. The study will also include an open-label extension, where all participants may have the opportunity to receive Atogepant to further assess its long-term safety and effectiveness. This trial is an important step in understanding how these medications can help people who suffer from migraines and improve their quality of life.

1 joining the study

Upon joining the study, eligibility is confirmed based on a documented history of migraine for at least 12 months and experiencing at least 4 migraine days per month.

2 randomization and initial treatment

Participants are randomly assigned to receive either atogepant or topiramate as preventive treatment for migraines.

Atogepant is administered orally in tablet form, while topiramate is also administered orally.

3 double-blind treatment period

The double-blind treatment period lasts for 24 weeks. During this time, neither the participants nor the researchers know which medication is being administered.

The primary goal is to assess treatment discontinuation due to adverse events.

4 evaluation of treatment effectiveness

Effectiveness is evaluated by measuring the reduction in the average number of migraine days per month during months 4 to 6.

Additional assessments include changes in headache impact and quality of life scores at week 24.

5 open-label safety extension

After the double-blind period, participants may enter an open-label extension to further evaluate the safety of the treatments.

In this phase, all participants receive the same treatment, and both participants and researchers know which medication is being administered.

Who Can Join the Study?

  • Must have a documented history of migraine (with or without aura) for at least 12 months before the first screening visit. A migraine is a type of headache that can cause severe pain, and aura refers to visual or sensory disturbances that some people experience before a migraine.
  • Must have a history of at least 4 migraine days per month and need preventive treatment for migraines. Preventive treatment is used to reduce the frequency and severity of migraines.
  • Both males and females are eligible to participate.
  • Participants from vulnerable populations are eligible. Vulnerable populations may include groups like children, elderly, or those with certain health conditions.

Who Cannot Join the Study?

  • Participants who are not able to follow the study instructions or procedures.
  • Individuals with a history of severe allergic reactions to any of the study medications.
  • People who have used other migraine prevention treatments recently.
  • Participants with certain medical conditions that might interfere with the study.
  • Women who are pregnant or breastfeeding.
  • Individuals who are currently participating in another clinical trial.
  • People with a history of drug or alcohol abuse.
  • Participants who have had recent surgery or plan to have surgery during the study.
  • Individuals with uncontrolled high blood pressure.
  • People with certain heart conditions that might affect their safety in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Pratia Prague s.r.o. Prague Czechia
Etg Neuroscience Sp. z o.o. Warsaw Poland
Praglandia s.r.o. Prague Czechia
Pratia Pardubice a.s. Pardubice Czechia
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Hospital Da Luz S.A. Lisbon Portugal
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Semmelweis University Budapest Hungary
Irccs San Raffaele Roma S.r.l. Rome Italy
Jessa Ziekenhuis Hasselt Belgium
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
CHU Gabriel-Montpied Clermont Ferrand France
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital De Santa Maria E.P.E. Lisbon Portugal
Klinische Forschung Hannover-Mitte GmbH Hanover Germany
Unidade Local De Saude De Amadora Sintra E.P.E. Amadora Portugal
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Rcmed Oddzial Sochaczew Sochaczew Poland
Klinische Forschung Hamburg GmbH Hamburg Germany
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
Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft Westerstede Germany
INEP medical s.r.o. Prague Czechia
Neurohk s.r.o. Chocen Czechia
Athleticomed Sp. z o.o. Bydgoszcz Poland
DRC Kft. Balatonfured Hungary
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie Kiel Germany
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH Ulm Germany
Clinexpert Kft. Budapest Hungary
Universita’ Campus Bio-medico Di Roma Rome Italy
HELIOS Kliniken Schwerin GmbH Schwerin Germany
Vrije Universiteit Brussel Jette Belgium
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH Bad Homburg Germany
Clintrial s.r.o. Prague Czechia
Hospices Civils De Lyon Lyon France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Charite Research Organisation GmbH Berlin Germany
Solumed Sp. z o.o. sp.k. Poznan Poland
Fakultni Thomayerova nemocnice Prague Czechia
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej Lublin Poland
A-Shine s.r.o. Plzen Czechia
University Of Debrecen Debrecen Hungary
Neuropraxis Muenchen Sued Unterhaching Germany
Mind Klinika Kft. Budapest Hungary
Neuro Centrum Science GmbH Erbach Germany
Gglapdcjforatmddog Hiqriadkfca Hoppegarten Germany
Ayunizllad Prcqncvh Hwivauqt Dw Pofwo Paris France
Nsozdmgojrvd Bdbrnyixp Bielefeld Germany
Ndanmlccpemvkv Fhocwhxsryrclur Bjwdsb Berlin Germany
Hjzelgdr Groqzn Dr Oucv Enzvej Almada Portugal
Uupqvcozgefvhpzapicqu Emays Ajx Essen Germany
Smzqbttck Kcrl Budapest Hungary
Igxucorb Zpoktyy Dc Bzywsetdrgogzjddr Oświęcim Poland
Stwvghtbbchhyc Dzt Bawfwsz Gbvm Böblingen Germany
Kxesatl Dtl Bjgfmmihgsud Bqghwql Linz Austria

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
13.10.2023
Belgium Belgium
Not recruiting
13.10.2023
Czechia Czechia
Not recruiting
13.10.2023
France France
Not recruiting
13.10.2023
Germany Germany
Not recruiting
13.10.2023
Hungary Hungary
Not recruiting
13.10.2023
Italy Italy
Not recruiting
13.10.2023
Poland Poland
Not recruiting
13.10.2023
Portugal Portugal
Not recruiting
13.10.2023

Trial locations

Investigated drugs:

Atogepant is a medication being studied for its ability to prevent migraines. It is taken by mouth and works by blocking certain receptors in the brain that are involved in the development of migraines. The trial aims to see how well people tolerate this medication and how safe it is for long-term use.

Topiramate is a medication commonly used to prevent migraines. It is also taken by mouth and works by calming overactive nerve cells in the brain. In this trial, it is used as a comparison to evaluate the effectiveness and safety of atogepant. The study looks at how well participants tolerate the highest dose of topiramate that they can handle.

Chronic and Episodic Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches often accompanied by nausea, vomiting, and sensitivity to light and sound. Chronic migraine involves headaches occurring on 15 or more days per month for more than three months, with at least eight days having migraine features. Episodic migraine, on the other hand, occurs less frequently, typically fewer than 15 days per month. The progression of migraines can vary, with some individuals experiencing an increase in frequency and severity over time. Migraine attacks can last from a few hours to several days and may be preceded by sensory disturbances known as aura. The condition can significantly impact daily activities and quality of life.

Trial ID:
2022-501172-25-00
Protocol code:
M22-061
NCT ID:
NCT05748483
Trial Phase:
Therapeutic confirmatory (Phase III)

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