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

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What is this study about?

This clinical trial is focused on studying the long-term safety and tolerability of a medication called Atogepant in children and teenagers aged 6 to 17 who experience Migraine. Migraines are severe headaches that can cause intense throbbing or pulsing in one area of the head, often accompanied by nausea, vomiting, and extreme sensitivity to light and sound. The purpose of this study is to understand how safe and tolerable Atogepant is when used over a long period to prevent migraines in young people.

Participants in the study will take Atogepant in the form of a tablet, which is taken orally. The study will monitor participants for any side effects or adverse events, which are unexpected medical problems that occur during treatment. This includes regular checks on their health through laboratory tests, heart monitoring using an Electrocardiogram (ECG), and assessments of vital signs like blood pressure and heart rate. The study will also look at any changes in mood or behavior, especially any thoughts of self-harm, using a tool called the Columbia-Suicide Severity Rating Scale.

The study is designed to last for a significant period, allowing researchers to gather comprehensive data on the long-term effects of Atogepant. Participants will be closely monitored throughout the study to ensure their safety and well-being. This research aims to provide valuable insights into the use of Atogepant for preventing migraines in children and teenagers, potentially offering a new option for managing this challenging condition.

1 initial visit

Upon joining the study, you will have an initial visit. During this visit, your eligibility will be confirmed based on your age, weight, and migraine history.

You will be asked about your medical history and any previous participation in related studies.

2 medication administration

You will begin taking the medication atogepant in the form of a tablet. This medication is taken orally.

The dosage and frequency will be determined by the study team and will be explained to you during the initial visit.

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 such as blood tests, heart monitoring (ECG), and vital sign measurements.

4 adverse event monitoring

You will be monitored for any adverse events, which are unexpected medical issues that may occur during the study.

If you experience any adverse events, you should report them to the study team immediately.

5 behavioral assessments

You will undergo behavioral assessments to evaluate any changes in your behavior or mood.

These assessments will include tools like the Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF2).

6 menstrual cycle assessments

If applicable, menstrual cycle assessments will be conducted to monitor any changes related to the medication.

7 study completion

The study is expected to continue until November 2029. Upon completion, you will have a final visit to assess your overall health and any long-term effects of the medication.

Who Can Join the Study?

  • Participants must be between 6 and 17 years of age (inclusive).
  • Participants must have a history of episodic or chronic migraine. Episodic migraine means having migraine attacks on some days, while chronic migraine means having them on many days each month.
  • Participants must have completed the lead-in Study M21-201, or the pharmacokinetic (PK) substudy in Study M21-201, or the lead-in Study M23-712. Pharmacokinetic refers to how the body absorbs, distributes, and gets rid of a drug.
  • Participants must weigh at least 20 kg (44 lbs) and less than 135 kg (298 lbs).
  • Participants must have a history of migraine with or without aura for at least 6 months. Aura refers to visual or sensory disturbances that can occur before a migraine attack.

Who Cannot Join the Study?

  • Participants who are not between the ages of 6 and 17 years old.
  • Participants who do not have a diagnosis of migraine.
  • Participants who are unable to comply with the study procedures.
  • Participants who have any other medical condition that the study doctors think might make it unsafe for them to participate.
  • Participants who are currently taking part in another clinical trial.
  • Participants who have a history of allergic reactions to the study medication or similar medications.
  • Participants who are pregnant or breastfeeding.
  • Participants who have a history of drug or alcohol abuse.
  • Participants who have a significant psychiatric disorder that is not well controlled.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Intercommunal Creteil Creteil France
Hospital Clinico San Carlos Madrid Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Spitalul Clinic de Copii “Dr. Victor Gomoiu” Bucharest Romania

Other Sites

Site Name City Country Status
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Hospital Universitario 12 De Octubre Madrid Spain
Haga Hospital Hague The Netherlands
Clinexpert Kft. Budapest Hungary
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaza Budapest Hungary
Virgen del Rocío University Hospital Sevilla Spain
Centre Hospitalier Universitaire De Toulouse Toulouse France
Hospital Da Luz S.A. Lisbon Portugal
Aalborg University Hospital Aalborg Denmark
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Vaestra Goetalandsregionen Vänersborg Sweden
Delta Health Care S.R.L. Bucharest Romania
Athleticomed Sp. z o.o. Bydgoszcz Poland
ZorgSaam Ziekenhuis Terneuzen The Netherlands
Specjalistyczne Gabinety Sp. z o.o. Cracow Poland
OHA-Med Sp. z o.o. Warsaw Poland
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Mind Klinika Kft. Budapest Hungary
Soedersjukhuset AB Stockholm Sweden
Indywidualna Specjalistyczna Praktyka Lekarska Lublin Poland
Centrum Leczenia MIGRE Wroclaw Poland
S-Medicon Kft. Budapest Hungary
Boerhaave Medisch Centrum Amsterdam The Netherlands
Rtewfk Mchomdvpxof Herning Denmark
Hcockk Hssadpgy Herlev Denmark
Hprnicts Di Ly Srmnw Cbho I Smij Prh Barcelona Spain
Ucrsziaxmh Oe Arlqcxo Edegem Belgium
Htfbshnn Vegq drkftgxv Barcelona Spain
Csyfes Hstpyoxtrv E Ueqizrxflidwk Dx Cdqnpah Enjfsi Coimbra Portugal

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
15.09.2023
Denmark Denmark
Recruiting
15.09.2023
France France
Not recruiting
15.09.2023
Hungary Hungary
Recruiting
15.09.2023
Italy Italy
Recruiting
15.09.2023
Poland Poland
Recruiting
15.09.2023
Portugal Portugal
Recruiting
15.09.2023
Romania Romania
Not recruiting
15.09.2023
Spain Spain
Recruiting
15.09.2023
Sweden Sweden
Recruiting
15.09.2023
The Netherlands The Netherlands
Recruiting
15.09.2023

Trial locations

Atogepant is a medication being studied for its ability to prevent migraines in children and teenagers aged 6 to 17. Migraines are severe headaches that can cause pain, nausea, and sensitivity to light and sound. Atogepant works by blocking certain signals in the brain that are thought to contribute to migraines. This study aims to see if atogepant is safe and well-tolerated when used over a long period. Participants in the trial will take atogepant regularly to help reduce the frequency and severity of their migraine attacks.

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 for hours to days and may vary in frequency and intensity. Some individuals experience warning symptoms known as aura, which can include visual disturbances or tingling sensations. The progression of migraine can involve different phases, including the prodrome, aura, headache, and postdrome phases. Over time, migraines can become more frequent or severe, affecting daily activities and quality of life.

Trial ID:
2022-501099-24-00
Protocol code:
M21-199
NCT ID:
NCT05707949
Trial Phase:
Therapeutic confirmatory (Phase III)

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