Study on the Safety and Effectiveness of Atogepant for Preventing Chronic Migraine in Children Aged 12 to 17

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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 preventive treatment of Chronic Migraine in children and teenagers aged 12 to 17. Chronic Migraine is a condition where individuals experience frequent migraine headaches, often more than 15 days a month. The study aims to evaluate how safe and effective Atogepant is when taken daily as a tablet.

Participants in the study will be randomly assigned to receive either Atogepant or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for 12 weeks, during which participants will take the assigned tablets daily. Throughout the study, researchers will monitor any side effects and changes in the frequency of migraine days. The goal is to see if Atogepant can reduce the number of migraine days and improve the quality of life for those taking it.

By the end of the study, researchers hope to gather enough information to determine if Atogepant is a safe and effective option for preventing migraines in young people. This could potentially lead to a new treatment option for those suffering from Chronic Migraine, helping them experience fewer headaches and improve their daily lives.

1 joining the study

Upon joining the study, participants will be informed about the purpose and procedures of the trial. The study aims to evaluate the safety and effectiveness of atogepant for preventing chronic migraine in individuals aged 12 to 17 years.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes verifying a history of migraine for at least six months and ensuring the participant’s weight is between 44 pounds (20 kg) and 298 pounds (135 kg).

3 medication administration

Participants will receive either atogepant or a placebo in the form of oral tablets. The medication is to be taken daily for a period of 12 weeks. The specific dosage will be provided by the study team.

4 ongoing monitoring

Throughout the 12-week period, participants will be monitored for any changes in migraine frequency and severity. This includes tracking the number of migraine days and headache days each month.

5 quality of life assessment

Participants will complete assessments to evaluate any changes in their quality of life and the impact of migraines on daily activities. This will be done using standardized questionnaires at the beginning and end of the study.

6 final evaluation

At the end of the 12-week period, a final evaluation will be conducted to assess the overall effectiveness of the treatment. This includes measuring any reduction in migraine days and improvements in quality of life.

Who Can Join the Study?

Must be between 12 and 17 years old.
Must weigh at least 20 kg (44 pounds) and less than 135 kg (298 pounds).
Must have a history of migraine (a type of headache) with or without aura (visual or sensory disturbances) for at least 6 months.
Must have used at least one oral medication (either over-the-counter or prescription) for treating migraines in the past or currently.
Both males and females can participate.

Who Cannot Join the Study?

Patients who do not have chronic migraine cannot participate. Chronic migraine means having headaches on 15 or more days each month, with at least 8 of those days being migraines.
Patients who are not between the ages of 12 to 17 years old cannot participate.
Both male and female patients can participate, but if you are not in this age range, you cannot join.
Patients who are part of a vulnerable population may not be eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Athleticomed Sp. z o.o.	Bydgoszcz	Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Specjalistyczne Gabinety Sp. z o.o.	Cracow	Poland
OHA-Med Sp. z o.o.	Warsaw	Poland
Hospital Da Luz S.A.	Lisbon	Portugal
Semmelweis University	Budapest	Hungary
Region Midtjylland	Aarhus	Denmark
Centro Hospitalar Universitario De Santo Antonio E.P.E.	Porto	Portugal
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Centrum Leczenia MIGRE	Wroclaw	Poland
CEBA Egeszseguegyi Bt.	Budapest	Hungary
Hzuzzh Hmfeqlux	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.07.2025
Hungary	Recruiting	01.07.2025
Italy	Recruiting	01.07.2025
Poland	Recruiting	01.07.2025
Portugal	Recruiting	01.07.2025
The Netherlands	Recruiting	01.07.2025

Trial locations

Investigated drugs:

Atogepant

Atogepant is a medication being studied for its ability to prevent chronic migraines in young people aged 12 to 17. It is taken daily and works by blocking a specific protein in the brain that is involved in the development of migraines. The goal of using atogepant in this trial is to see if it can reduce the frequency and severity of migraine attacks in these young patients, making their lives more comfortable and less disrupted by headaches.

Chronic Migraine – Chronic migraine is a neurological condition characterized by frequent headache episodes. It involves experiencing headaches on 15 or more days per month, with at least 8 of those days having features of migraine headaches. Symptoms often include throbbing pain, sensitivity to light and sound, nausea, and sometimes visual disturbances. The condition can develop from episodic migraines, where the frequency of headaches increases over time. Factors such as stress, hormonal changes, and certain foods can trigger or worsen the condition. Chronic migraine can significantly impact daily activities and quality of life.

Trial ID:

2024-513836-28-00

Protocol code:

M23-712

NCT ID:

NCT06810505

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Effectiveness of Atogepant for Preventing Chronic Migraine in Children Aged 12 to 17

What is this study about?

Who Can Join the Study?

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