A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate long term safety and tolerability of ubrogepant in the acute treatment of migraine in pediatric participants.
Ubrogepant is a drug approved for the acute treatment of migraine in adults. Pediatric participants (aged 6-17 years) with a history of migraine will be enrolled. Participants who completed the lead-in Study 3110-305-002, as well as those who were placebo responders and screen failed, will be eligible to enroll into this study. Around 1200 participants will be enrolled in the study at approximately 120 sites in the United States.
Participants may receive ubrogepant oral tables to treat up to 8 migraine attacks of any intensity per month. There will be an option to take a second dose of study intervention (identical to initial dose), or rescue medication, starting 2 hours after the initial dose. The study duration will be up to 54 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.
Inclusion Criteria:
Exclusion Criteria:
Washington D.C., District of Columbia 20011, United States
Boynton Beach, Florida 33436-7245, United States
Gulf Breeze, Florida 32561-4495, United States
Winter Park, Florida 32789-7111, United States
Atlanta, Georgia 30328, United States
Stockbridge, Georgia 30281, United States
Overland Park, Kansas 66210-2761, United States
Wichita, Kansas 67205-1138, United States
Burnsville, Minnesota 55337-6732, United States
Petal, Mississippi 39465-2932, United States
Papillion, Nebraska 68046-4131, United States
Nashua, New Hampshire 03060-3483, United States
Philadelphia, Pennsylvania 19104-4319, United States
Austin, Texas 78723-3079, United States
Woodstock, Vermont 05091, United States
Norfolk, Virginia 23507-1901, United States