A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years
{ "Study of Atogepant for Chronic Migraine in Teens", "This study is looking at an oral tablet called atogepant to see how safe it is and how well it works to prevent chronic migraine in young people aged 12 to 17. Chronic migraine is a type of headache that happens often and can cause throbbing pain, nausea, and sensitivity to light and sound. Participants will receive either atogepant or a placebo (a pill that looks like the study medicine but has no active drug). We will be watching for any side effects and measuring how much atogepant reduces the number of migraine days over about 12 weeks. Atogepant is already approved for adults with migraine, and this study aims to see if it can help teens too.", "design": "This interventional study plans to enroll 420 participants aged 12 to 17 years. Participants will be randomly assigned to receive either atogepant or a placebo.", "commitments": "Participants will take an oral tablet and track their migraine days using an eDiary for at least 20 out of 28 days during screening. The study will assess adverse events and changes in migraine days for up to approximately 16 weeks.", "compensation": "Not stated in the trial record.", "follow_up": "The study will follow participants for adverse events for up to approximately 16 weeks and measure changes in migraine days through Week 12.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years
At a glance
Conditions
Where it's being run
64 sites across 45 statesStudy leadership
- ABBVIE INC. · STUDY_DIRECTOR · AbbVie
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Number of Participants Experiencing Adverse Events (AEs)Up to approximately 16 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
- Change From Baseline in Mean Monthly Migraine DaysBaseline (Week 0) through Week 12
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.