Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)

Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)

Brief Summary:
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.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date: January 14, 2022
Estimated Primary Completion Date: March 9, 2027
Estimated Study Completion Date: March 9, 2027

Arms:
- Experimental: Ubrogepant Dose A (12 to 17 Years Old)
- Experimental: Ubrogepant Dose B (6 to 11 Years Old)

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