Study on the Safety and Effectiveness of Atogepant for Preventing Episodic Migraine in Children and Teens Aged 6 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 treatment of episodic migraine in children and teenagers aged 6 to 17 years. Episodic migraine is a type of headache that occurs less frequently than chronic migraine, typically with fewer than 15 headache days per month. The study aims to evaluate the safety and effectiveness of two different doses of Atogepant, which is taken in tablet form.

The purpose of the study is to assess how well Atogepant works in reducing the number of migraine days each month over a 12-week period. Participants 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 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 trial.

Throughout the study, participants will take the medication daily and will be monitored for any changes in their migraine symptoms and overall health. The study will also track any side effects that may occur. By the end of the 12-week period, researchers hope to gather valuable information on the potential benefits and safety of Atogepant for young people with episodic migraine.

1 joining the study

Upon joining the study, participants will be informed about the purpose and procedures involved in the trial. The study aims to evaluate the safety and effectiveness of two doses of atogepant for treating episodic migraine in children and teenagers aged 6 to 17 years.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes checking weight, which must be between 20 kg (44 lbs) and 135 kg (298 lbs), and reviewing the history of episodic migraine, which should be consistent with a diagnosis for at least 6 months.

3 baseline period

Participants will record their migraine and headache days over a 28-day baseline period using an electronic diary. This helps establish a baseline for comparison during the treatment phase.

4 treatment phase

Participants will be randomly assigned to receive either a low or high dose of atogepant or a placebo. The medication is taken orally in tablet form once daily for 12 weeks.

The low dose is 10 mg, and the high dose is 60 mg. The placebo tablets are designed to look like the atogepant tablets but do not contain the active ingredient.

5 ongoing monitoring

Throughout the 12-week treatment period, participants will continue to record their migraine and headache days, as well as any use of acute medication, in their electronic diary.

Regular check-ins with the study team will occur to monitor health and any side effects.

6 final assessment

At the end of the 12-week period, participants will undergo a final assessment. This includes evaluating changes in migraine and headache days, medication use, and quality of life scores.

The study aims to determine if there is a significant reduction in migraine days and improvement in quality of life.

Who Can Join the Study?

Participant must weigh between 20 kg (44 lbs) and 135 kg (298 lbs).
Participant must have a history of episodic migraine for at least 6 months. Episodic migraine means having migraine attacks that occur on some days but not every day.
Participant must have had 4 to 14 migraine days and less than 15 headache days in the last 28 days, as recorded in an electronic diary (eDiary).
To join a specific part of the study, called the PK substudy, participants must be between 6 to 11 years old and have a history of migraine. The doctor must also agree that preventive treatment for migraine is suitable for them.

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.
Patients who are currently taking other medications that might interfere with the study medication are not eligible. This means if you are taking certain drugs that could affect how the study drug works, you cannot join.
Patients with serious health conditions that could affect their safety during the study cannot participate. Serious health conditions are illnesses that can make you very sick or need a lot of medical care.
Patients who have participated in another clinical trial within the last 30 days are not eligible. This means if you were part of another study recently, you need to wait before joining this one.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients who have a history of substance abuse are not eligible. 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 interfere with their ability to follow study instructions cannot participate. This means if you have a mental illness that makes it hard to understand or remember things, you might not be able to join.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Spitalul Clinic de Psihiatrie “Dr. Gheorghe Preda” Sibiu	Sibiu	Romania
Hospital Clinico San Carlos	Madrid	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Centre Hospitalier Intercommunal Creteil	Creteil	France
Spitalul Clinic de Copii “Dr. Victor Gomoiu”	Bucharest	Romania

Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Soedersjukhuset AB	Stockholm	Sweden
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaza	Budapest	Hungary
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Semmelweis University	Budapest	Hungary
Aalborg University Hospital	Aalborg	Denmark
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Hospital Universitario 12 De Octubre	Madrid	Spain
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
Clinexpert Kft.	Budapest	Hungary
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Neurologie Centrum Amsterdam	Amsterdam	The Netherlands
Centrum Leczenia MIGRE	Wroclaw	Poland
Mind Klinika Kft.	Budapest	Hungary
Indywidualna Specjalistyczna Praktyka Lekarska	Lublin	Poland
Stfmexawo Kozk	Budapest	Hungary
Hxilsw Hzadxbve	Herlev	Denmark
Rxejmf Mmrxoaycysg	Herning	Denmark
Uzsyyjfagh Oe Adarfbc	Edegem	Belgium
Hjnsqqif Vgup dqzaiqhy	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	15.08.2023
Denmark	Recruiting	15.08.2023
France	Recruiting	15.08.2023
Hungary	Recruiting	15.08.2023
Italy	Recruiting	15.08.2023
Poland	Recruiting	15.08.2023
Romania	Not recruiting	15.08.2023
Spain	Recruiting	15.08.2023
Sweden	Recruiting	15.08.2023
The Netherlands	Recruiting	15.08.2023

Trial locations

Investigated drugs:

Atogepant

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 intense pain, nausea, and sensitivity to light and sound. Atogepant works by blocking a specific protein in the brain that is involved in the development of migraines. By doing this, it aims to reduce the frequency and severity of migraine attacks, helping young patients experience fewer headaches and improve their quality of life. The study is testing the safety and effectiveness of atogepant when taken daily.

Episodic Migraine – Episodic migraine is a neurological condition characterized by recurrent headaches that occur on fewer than 15 days per month. These headaches are often moderate to severe in intensity and can be accompanied by symptoms such as nausea, vomiting, and sensitivity to light and sound. The progression of episodic migraine involves the occurrence of headache attacks that can last from a few hours to several days. The frequency and severity of these attacks can vary widely among individuals. Over time, some individuals may experience changes in the pattern or frequency of their migraine episodes. The condition is distinct from chronic migraine, which involves headaches on 15 or more days per month.

Trial ID:

2022-501100-94-00

Protocol code:

M21-201

NCT ID:

NCT05711394

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Effectiveness of Atogepant for Preventing Episodic Migraine in Children and Teens Aged 6 to 17

What is this study about?

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Who Cannot Join the Study?