Study Summary
This trial studies a medicine, atogepant, to see how safe and effective it is in children (ages 6-17) with episodic migraine headaches. Participants will be randomized to receive placebo, low or high doses of the medicine for 12 weeks.
- Migraine with Aura
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: Baseline (Week 0) to 3 Months
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
8 Treatment Groups
Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)
1 of 8
Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)
1 of 8
Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)
1 of 8
Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)
1 of 8
Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)
1 of 8
Double-Blind Treatment Period: Placebo (6-11 yrs)
1 of 8
Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)
1 of 8
Double-Blind Treatment Period: Placebo (12-17 yrs)
1 of 8
Experimental Treatment
450 Total Participants · 8 Treatment Groups
Primary Treatment: Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs) · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 6 - 17 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Does this clinical trial include any participants of advanced age?
"The study seeks to enrol participants who are six years old or older, but not yet 17." - Anonymous Online Contributor
How many geographic areas have been selected to host this research endeavor?
"This trial is taking place in 45 different medical centres, ranging from Little Rock to Lafayette and Anaheim. To reduce potential travel burdens, it would be most sensible for patients to participate at the site nearest them." - Anonymous Online Contributor
Has the Federal Drug Administration (FDA) sanctioned Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)?
"This Phase 3 trial has accumulated sufficient evidence to rate the safety of Open-Label PK Substudy: Atogepant Dose A (6-11 yrs) as a 3." - Anonymous Online Contributor
Does this medical experiment have any openings for participants?
"Data housed on clinicaltrials.gov indicates that this particular trial, which was originally posted in February of 2023 and last updated at the end of January, is no longer seeking participants. However, 159 other medical studies are actively recruiting patients currently." - Anonymous Online Contributor
What prerequisites must individuals meet to be eligible for enrollment in this clinical trial?
"This clinical trial seeks 450 kids aged 6 to 17 who suffer from migraine with aura. Applicants must weigh between 44 lbs and 298 lbs, have a history of episodic migraines (in accordance with the International Classification of Headache Disorders), experience 4-14 migraine days in a 28 day period according to their eDiary, and be eligible for preventive treatment (for those interested in participating in the PK substudy)." - Anonymous Online Contributor