Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine

Study Identifier
M21-199
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2022-501099-24-00
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Study Details

Medical Condition
  • Migraine - General
  • Study Drug
  • Atogepant
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    6 - 17 Years

    Protocol Summary

    A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine.

    Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of migraine. This is a Phase 3, open-label study of atogepant in participants with a history of migraine. Participants must have completed participation in another study of atogepant (lead-in study). Participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and \>= 15 headache days and \>= 8 migraine days for chronic migraine in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study at approximately 100 sites worldwide.

    Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 52 Weeks.

    There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Rehabilitation & Neurological Services /ID# 250910
    Huntsville, Alabama, United States, 35805-4046
    Status
    Not applicable
    Location
    Preferred Research Partners /ID# 250937
    Little Rock, Arkansas, United States, 72211
    Status
    Not applicable
    Location
    Advanced Research Center /ID# 251616
    Anaheim, California, United States, 92805
    Status
    Not applicable
    Location
    Sunwise Clinical Research /ID# 250913
    Lafayette, California, United States, 94549-4579
    Status
    Not applicable
    Location
    Alliance for Research Alliance for Wellness /ID# 250911
    Long Beach, California, United States, 90807
    Status
    Not applicable
    Location
    Excell Research, Inc /ID# 251611
    Oceanside, California, United States, 92056
    Status
    Not applicable
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