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)

Conditions

• Migraine

Eligibility Criteria

Sex

ALL

Age

6 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Ubrogepant — DRUG
  Oral Tablet

Study Details

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.

Key Dates

Start date

Jan 14, 2022

Status verified

Jul 2025

Primary completion

Jan 31, 2028

Completion

Jan 31, 2028

Study Design

Enrollment

1,200 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ubrogepant Dose A (12 to 17 Years Old)
  Participants will receive oral tablets of ubrogepant Dose A for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, at least 2 hours after initial dose for headache of any intensity.
• Experimental: Ubrogepant Dose B (6 to 11 Years Old)
  Participants will receive the highest dose of oral tablets of ubrogepant tested in Study 3110-305-002 for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, at least 2 hours after initial dose for headache of any intensity.

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) [ Time Frame: up to 54 weeks ]

Locations (109)

Find similar trials in Huntsville, AL

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