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Taking people in NetherlandsPhase 3

Long-term safety of atogepant tablets in children with migraine

Tests long-term safety of atogepant tablets in children aged 6 to 17 with migraine.

Key facts

Who runs it
AbbVie
Where
's-Gravenhage, Amsterdam, Nijmegen, and Terneuzen, NetherlandsSee the 4 sitesAlso in 16 other countries, 95 sites
Registry title
Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine
Status
Enrolling by invitation
Phase
Phase 3
People taking part
650 people, planned
Started
5 Jun 2023
Expected to end
Apr 2032
Type of study
Interventional, 2 groups
Treatments tested
  • Atogepant
Record updated
11 August 2025

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 migraine who finished an earlier atogepant study. It checks long-term safety of atogepant tablets.

Age
6 to 17 years
Sex
All sexes
Disease stage
History of migraine, with or without aura, for at least 6 months. Episodic migraine for ages 6 to 17, chronic migraine for ages 12 to 17.
Earlier treatment
Must have completed the lead-in Study M21-201, its pharmacokinetic (PK) substudy, or the lead-in Study M23-712.

Main reasons for not taking part

  • New daily persistent headache, cluster-type headache or painful cranial neuropathy
  • Clinically significant blood, hormone, lung, kidney, liver, gut, heart or nerve disease
  • Weight under 20 kg (44 lb) or 135 kg (298 lb) and over

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Participants must be between 6 and 17 years of age (inclusive), with a history of episodic (ages 6 to 17) or chronic (ages 12 to 17) migraine
  • The participant 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
  • Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs)
  • A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3; 2018) for at least 6 months

Who cannot take part

  • Have any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular, or neurologic disease
  • 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 Netherlands

Also in 16 other countries, 95 sites

  • Haga Hospital's-Gravenhage, NetherlandsTaking people
  • Boerhaave Medisch CentrumAmsterdam, NetherlandsTaking people
  • Canisius-Wilhelmina HospitalNijmegen, NetherlandsTaking people
  • ZorgSaam ZiekenhuisTerneuzen, NetherlandsTaking 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 participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine.

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 migraine. This is a Phase 3, open-label study of atogepant in participants with a history of migraine. Participants must have completed participation in another study of atogepant (lead-in study). Participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and >= 15 headache days and >= 8 migraine days for chronic migraine in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study at approximately 100 sites worldwide.

Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 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 2 groups in the trial

  • Atogepant Dose A (12-17 yrs)Treatment being tested

    Participant aged 12-17 will receive oral tablets of atogepant Dose A once a day for up to 52 weeks.

    Treatment: Atogepant

  • Atogepant Dose B (6-11 yrs)Treatment being tested

    Participants aged 6-11 will receive the highest dose of oral tablets of atogepant tested in the lead-in study M21-201.

    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 Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Atogepant in Pediatric Subjects 6 to 17 Years of Age With Migraine
Plain-language title
Long-term safety of atogepant tablets in children with migraineGenerated 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 NCT05707949, who can take part
Record updated
11 August 2025