At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Atogepant (drug), Placebo-Matching Atogepant (drug)
- How long the study runs
- Study runs about 60 months (dates as stated)
- About the drug or intervention
- Atogepant — drug: Oral Tablet · Placebo-Matching Atogepant — drug: Oral Tablet
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 6 Years to 17 Years
- Who
- All
- Number of participants
- 450
- Started
- 2023-05-01
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for episodic migraine
- • Phase3 - 450 participants
- • A migraine is a moderate to severe headache on one side of the head
Who can take part?
- • Ages 6 Years to 17 Years
- • Diagnosed with episodic migraine
Where?
- • London - Great Ormond Street Children's Hospital /ID# 262933
- • Gillingham - Medway NHS Foundation Trust /ID# 249065
- • Aberdeen - NHS Grampian /ID# 249067
- • Stockport - Stepping Hill Hospital-Stockport NHS foundation trust /ID# 261121
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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. 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 6 Years - 17 Years
- Who can join: All genders
What the study is looking for
- ✓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...
- ✓Participant has to have 4 to 14 migraine days and \< 15 headache days in the 28-day baseline period per eDiary.
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),...
See the full criteria
Where Is This Study? (4 UK sites)
Great Ormond Street Children's Hospital /ID# 262933
London WC1N 3HZ, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700Medway NHS Foundation Trust /ID# 249065
Gillingham ME7 5NY, United Kingdom
NHS Grampian /ID# 249067
Aberdeen AB15 6RE, United Kingdom
Stepping Hill Hospital-Stockport NHS foundation trust /ID# 261121
Stockport SK2 7JE, United Kingdom
Research, Development & Innovation Office
research.development@stockport.nhs.uk0161 419 5893How to Get in Touch
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