Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)
Phase 3
1,059
about 4.4 years
6–17
120 sites in AL, AR, AZ +33
About this study
Researchers are testing a treatment called ubrogepant, which is used to treat migraines in adults. The trial will evaluate how safe and effective this treatment is for children and adolescents aged 6 to 17 years old who have migraine headaches. Participants will receive either ubrogepant or a placebo (inactive pill) for up to 6 months.
Based on ClinicalTrials.gov records.
What participants do
- 1.Take Placebo-Matching Ubrogepant
- 2.Take Ubrogepant
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
NERVOUS SYSTEM, ubrogepant
oral (Oral Tablet)
Primary: Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Secondary: Change From Baseline in Electrocardiograms (ECGs) in pediatric participants aged 6 to 17 years, Number of Participants with Adverse Events (AE), Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose in pediatric participants aged 12 to 17 years, Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose in pediatric participants aged 6 to 17 years, Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose in pediatric participants aged 6 to 17 years, Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements in pediatric participants aged 6 to 17 years, Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years, Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 11 years
Neurology