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

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What is this study about?

This clinical trial is focused on studying the prevention of migraine, a condition characterized by severe headaches that can be accompanied by symptoms like nausea and sensitivity to light. The study includes participants who experience either chronic migraine or episodic migraine. Chronic migraine involves headaches on 15 or more days per month, while episodic migraine occurs less frequently. The treatment being tested is a medication called Atogepant, which is taken orally in the form of a tablet.

The purpose of this study is to evaluate the long-term safety and tolerability of Atogepant when used over a period of 156 weeks. Participants will take a 60 mg dose of Atogepant once daily. The study is designed to observe how well participants tolerate the medication over this extended period and to monitor any side effects that may arise. This is an open-label study, meaning that both the researchers and participants know which treatment is being administered.

Throughout the study, participants will be regularly monitored for any adverse events, which are any unwanted effects that occur during the trial. The study will also assess any significant changes in laboratory test results, heart function as measured by electrocardiograms (ECGs), and vital signs such as blood pressure and heart rate. The goal is to ensure that Atogepant is safe for long-term use in preventing migraines in those who suffer from this condition.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. This study aims to evaluate the long-term safety and tolerability of the medication atogepant for preventing migraines.

You will be required to have completed specific visits from previous related studies without significant issues or adverse events.

2 medication administration

You will take an oral tablet of atogepant at a dose of 60 mg once daily. This medication is intended to help prevent migraines.

The duration of this medication administration is planned for up to 156 weeks.

3 regular check-ups

Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication.

These check-ups will include assessments of laboratory values, electrocardiograms (ECGs), and vital signs to ensure your safety.

4 reporting side effects

You are encouraged to report any side effects or unusual symptoms you experience during the study.

The primary focus is on identifying any treatment-emergent adverse events, which are side effects that occur after starting the medication.

5 completion of the study

The study is expected to conclude by October 2025. Upon completion, your participation will help in understanding the long-term safety of atogepant for migraine prevention.

Your contribution is valuable in assessing the medication’s effects over an extended period.

Who Can Join the Study?

  • You must have completed Visit 7, and Visit 8 if needed, of Study 3101-303-002 or Study 3101-304-002 without any major issues following the study rules.
  • You must not have had any serious side effects that could mean the treatment is not safe for you.
  • You must be diagnosed with Chronic or Episodic Migraine. This includes migraines with or without aura, or chronic migraines. An aura is a visual or sensory disturbance that can happen before a migraine.
  • Both men and women can participate in the study.
  • The study includes people who might be considered part of a vulnerable population. This means groups of people who might need special protection or care.

Who Cannot Join the Study?

  • Participants cannot join if they have any other serious health conditions that might interfere with the study.
  • Individuals who are currently participating in another clinical trial are not eligible.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Participants who have had a recent surgery or plan to have surgery during the study period are excluded.
  • People with a history of drug or alcohol abuse in the past year are not allowed to participate.
  • Individuals who have an allergy or sensitivity to the study medication or similar drugs cannot join.
  • Participants who are unable to comply with the study procedures or follow-up visits are not eligible.
  • Anyone with a history of certain mental health disorders that are not well controlled is excluded.
  • Individuals who have used certain medications that might interfere with the study drug within a specified time frame before the study starts are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Neuropraxis Muenchen-Sued Unterhaching Germany
University Hospital Jena KöR Jena Germany

Other Sites

Site Name City Country Status
Pratia Prague s.r.o. Prague Czechia
CHU Gabriel-Montpied Clermont Ferrand France
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Klinische Forschung Hannover-Mitte GmbH Hanover 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
Solumed Sp. z o.o. sp.k. Poznan Poland
INEP medical s.r.o. Prague Czechia
Neurohk s.r.o. Chocen Czechia
Hospital Clinico Universitario De Valladolid Valladolid Spain
ZorgSaam Ziekenhuis Terneuzen The Netherlands
Specjalistyczne Gabinety Sp. z o.o. Cracow Poland
Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie Kiel Germany
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH Ulm Germany
Vitos Orthopaedische Klinik Kassel gGmbH Kassel Germany
Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft Westerstede Germany
Euromedis Sp. z o.o. Szczecin Poland
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Clinexpert Kft. Budapest Hungary
Clintrial s.r.o. Prague Czechia
A-Shine s.r.o. Plzen Czechia
Pratia Pardubice a.s. Pardubice Czechia
Virgen del Rocío University Hospital Sevilla Spain
Universita’ Campus Bio-medico Di Roma Rome Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Irccs San Raffaele Roma S.r.l. Rome Italy
Pratia S.A. Skorzewo Poland
Vestra Clinics s.r.o. Rychnov Nad Kneznou Czechia
Centre Hospitalier Universitaire De Nice Nice France
Rigshospitalet Copenhagen Denmark
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej Lublin Poland
Fakultni Thomayerova nemocnice Prague Czechia
Forbeli s.r.o. Prague Czechia
Centrum Leczenia MIGRE Wroclaw Poland
S-Medicon Egészségügyi Szolgáltató Kft. Budapest Hungary
Intermed Institut fuer medizinische Forschung und Arzneimittelsicherheit GmbH Wiesbaden Germany
Ulzueiyywonzatsttldbt Ehaal Aaf Essen Germany
Bmyayllkfzvzrvnwx sslrgy Kladno Czechia
Apavawm Sxwzhokfl Lqqaip Ajzhzhdv Slctufb Lsmrhqxaahfyly L'aquila Italy
Cpuwfgp Ljvqitin Pedckayv I Manwuhn Sufc Cracow Poland
Djqp Mxhbqxg saceia Prague Czechia
Pfsmyw Dve Gatuekyk Essen Germany
Azaawofdlw Prndlioq Hpjdgllf Dq Mrbrpntqo Marseille France
Ncffqdjt Zrtm sltmli Zlin Czechia
Iaflxmfo da Cdrtnpfwgnou Hnrkwggvxok Ujsgnlrewgtpm di Spamm Ejfvzny (oamhxhf Saint Priest En Jarez France
Hqcfwipu Vxwm dpnhdooo Barcelona Spain

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
02.09.2021
Denmark Denmark
Not recruiting
02.09.2021
France France
Not recruiting
02.09.2021
Germany Germany
Not recruiting
02.09.2021
Hungary Hungary
Not recruiting
02.09.2021
Italy Italy
Not recruiting
02.09.2021
Poland Poland
Not recruiting
02.09.2021
Spain Spain
Not recruiting
02.09.2021
The Netherlands The Netherlands
Not recruiting
02.09.2021

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 a specific protein in the brain that is involved in the development of migraines. This study is looking at how safe and well-tolerated atogepant is when used over a long period, specifically for people who experience chronic or episodic migraines. The goal is to see if it can help reduce the frequency and severity of migraine attacks over time.

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. It can occur with or without aura, which are sensory disturbances that can include visual changes or tingling sensations. Migraine attacks can last from a few hours to several days and may vary in frequency from episodic to chronic. Chronic migraine is defined as having headaches on 15 or more days per month for more than three months, with migraine features on at least eight of those days. The progression of migraine can involve an increase in the frequency and severity of attacks over time. Factors such as stress, hormonal changes, and certain foods or drinks can trigger or worsen migraine episodes.

Trial ID:
2023-507096-21-00
Protocol code:
3101-312-002
NCT ID:
NCT04686136
Trial Phase:
Therapeutic confirmatory (Phase III)

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