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Taking people in HungaryPhase 3

Tests atogepant tablets for preventing migraine in children and teens

Tests atogepant tablets to prevent episodic migraine in children aged 6 to 17.

Key facts

Who runs it
AbbVie
Where
Budapest, Budapest II, Budapest III, Budapest VIII, and Budapest Xiv, HungarySee the 6 sitesAlso in 15 other countries, 98 sites
Registry title
A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine
Status
Recruiting
Phase
Phase 3
People taking part
450 people, planned
Started
1 May 2023
Expected to end
May 2028
Type of study
Interventional, 8 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Atogepant
  • Placebo-Matching Atogepant
Record updated
6 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 6 to 17 with episodic migraine. It tests a daily atogepant tablet against placebo for 12 weeks.

Age
6 to 17 years
Sex
All sexes
Disease stage
Episodic migraine with or without aura for at least 6 months. 4 to 14 migraine days and fewer than 15 headache days in the 28-day baseline period.

Main reasons for not taking part

  • Migraine brainstem aura, hemiplegic migraine or retinal migraine
  • Current chronic migraine
  • Current new daily persistent headache, cluster-type headache or painful cranial neuropathy
  • Weight under 20 kg (44 lb) or 135 kg (298 lb) and over

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs)
  • History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months
  • Participant has to have 4 to 14 migraine days and < 15 headache days in the 28-day baseline period per eDiary
  • To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine (consistent with a diagnosis according to the ICHD-3 [2018]) and per investigator judgment is appropriate to receive preventive treatment for migraine

Who cannot take part

  • History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018)
  • Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018)
  • Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 17 years old?

Where in Hungary

Also in 15 other countries, 98 sites

  • S-Medicon Kft.Budapest, HungaryTaking people
  • Semmelweis UniversityBudapest, HungaryTaking people
  • MIND Klinika Kft.Budapest II, HungaryTaking people
  • Clinexpert Kft.Budapest III, HungaryTaking people
  • Semmelweis UniversityBudapest VIII, HungaryTaking people
  • Magyarorszagi Reformatus Egyhaz Bethesda GyermekkorhazaBudapest Xiv, HungaryTaking people

About the trial

What the trial wants to find out

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17.

Read full original descriptionShow less

Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide.

Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks.

There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

The 8 groups in the trial

  • Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)Treatment being tested

    Participants aged 6 to 11 will receive oral tablets of atogepant Dose A to determine appropriate dose for the 6-11 year old group in double-blind treatment period.

    Treatment: Atogepant

  • Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)Treatment being tested

    Participants aged 6 to 11 will receive oral tablets of atogepant Dose B to determine appropriate dose for the 6-11 year old group in double-blind treatment period.

    Treatment: Atogepant

  • Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)Treatment being tested

    Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.

    Treatment: Atogepant

  • Double-Blind Treatment Period: Placebo (12-17 yrs)Placebo, for comparison

    Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.

    Treatment: Placebo-Matching Atogepant

  • Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)Treatment being tested

    Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.

    Treatment: Atogepant

  • Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)Treatment being tested

    Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.

    Treatment: Atogepant

  • Double-Blind Treatment Period: Placebo (6-11 yrs)Placebo, for comparison

    Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.

    Treatment: Placebo-Matching Atogepant

  • Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)Treatment being tested

    Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.

    Treatment: Atogepant

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age.
Plain-language title
Tests atogepant tablets for preventing migraine in children and teensGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05711394, who can take part
Publications
Record updated
6 October 2026