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)

Study Identifier
3110-306-002
CT.gov Identifier
NCT05127954
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Migraine - General
    • Study Drug
  • Ubrogepant
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    6 - 17 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Completers of the lead-in Study 3110-305-002 (in the main study or PK cohort) or those who screen failed due to being placebo responders. * Demonstrated an acceptable degree of compliance with study procedures in the lead-in study and who, in the investigator's clinical judgment, did not experience an AE that may indicate an unacceptable safety risk for this study.
    Exclusion Criteria:
    * Requirement for any medication (eg, barbiturates) or diet (eg, grapefruit juice) that is on the list of prohibited concomitant medications that cannot be discontinued or switched to an allowable, alternative medication at Visit 1. * An ECG with clinically significant abnormalities at Visit 1 as determined by the investigator. * Clinically significant abnormalities in physical examination at Visit 1, as determined by the investigator. * Significant risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator; participants should be excluded if they report suicidal ideation with intent, with or without a plan (ie, Type 4 or 5 on the C-SSRS), or report suicidal behavior at Visit 1 * Any medical or other reason (eg, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study) that, in the investigator's opinion, might indicate that the participant is unsuitable for the study.

    Protocol 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 Locations

    Location
    Status
    Location
    Rehabilitation & Neurological Services /ID# 240054
    Huntsville, Alabama, United States, 35805-4046
    Status
    Not applicable
    Location
    The Center for Clinical Trials - Saraland /ID# 239448
    Saraland, Alabama, United States, 36571
    Status
    Not applicable
    Location
    Preferred Research Partners /ID# 238979
    Little Rock, Arkansas, United States, 72211
    Status
    Not applicable
    Location
    Advanced Research Center /ID# 238967
    Anaheim, California, United States, 92805
    Status
    Not applicable
    Location
    Neuro Pain Medical Center /ID# 239135
    Fresno, California, United States, 93710
    Status
    Not applicable
    Location
    Alliance for Research Alliance for Wellness /ID# 233497
    Long Beach, California, United States, 90807
    Status
    Not applicable
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