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 for Atogepant (drug)
- How long the study runs
- Study runs about 73 months (dates as stated)
- About the drug or intervention
- Atogepant — drug: Oral tablet · Placebo for Atogepant — drug: Oral tablet
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 12 Years to 17 Years
- Who
- All
- Number of participants
- 420
- Started
- 2025-02-13
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for chronic migraine
- • Phase3 - 420 participants
- • Migraine is a disease that most often causes moderate to severe headache on one side of the head
Who can take part?
- • Ages 12 Years to 17 Years
- • Diagnosed with chronic migraine
Where?
- • London - Great Ormond Street Children's Hospital /ID# 271550
- • Gillingham - Medway Maritime Hospital /ID# 271885
- • Aberdeen - Royal Aberdeen Children's Hospital /ID# 271664
- • Leeds - Leeds Teaching Hospitals NHS Trust /ID# 273449
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Migraine is a disease that most often causes 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. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age. Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world. Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks. Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, 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: 12 Years - 17 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ completed the eDiary for a minimum of 20 out of 28 days
What the study is looking for
- ✓During the last 28 days of the screening/baseline period, and as per eDiary:
- ✓Participant must have completed the eDiary for a minimum of 20 out of 28 days.
- ✓Participant has \>= 15 headache days.
- ✓Participant has \>= 8 migraine days.
Who cannot take part
- ✗Clinically significant hypertension per investigator's judgment.
- ✗History of any clinically significant blood, endocrine, lung, kidney, liver, gastrointestinal,...
See the full criteria
Where Is This Study? (5 UK sites)
Great Ormond Street Children's Hospital /ID# 271550
London WC1N 3HZ, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700Medway Maritime Hospital /ID# 271885
Gillingham ME7 5NY, United Kingdom
Royal Aberdeen Children's Hospital /ID# 271664
Aberdeen AB25 2ZG, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 273449
Leeds LS9 7TF, United Kingdom
Stepping Hill Hospital-Stockport NHS foundation trust /ID# 271883
Stockport SK2 7JE, United Kingdom
Research, Development & Innovation Office
research.development@stockport.nhs.uk0161 419 5893How to Get in Touch
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