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
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Placebo-Matching Ubrogepant
- 2.Take Ubrogepant
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
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