Featured Trial

A Phase 3, Multicenter, 12‑Week, Double Blind, Placebo‑Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age

Study Identifier
M23-712
CT.gov Identifier
NCT06810505
EudraCT Identifier
Not available
EUCTIS ID
2024-513836-28-00
For general inquiries, please contact

844-663-3742 or [email protected]

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Study Details

The HORIZON study is a clinical research study for children diagnosed with chronic migraine aged 12 to 17. Migraine is a severe, chronic neurological disease where you experience recurring attacks of headaches, sensory disturbances, and other symptoms. It is one of the most common childhood ailments, affecting an estimated 7% to 10% of children.

The HORIZON Study is evaluating an investigational study drug (atogepant) for the prevention of migraine headaches in children between the ages of 12 to 17. The investigational study drug is currently approved to treat migraine in adults. The safety and effectiveness of this investigational study drug in children is unknown.

Participation in this study is voluntary. Whether or not you and your child decide to participate in this study will not affect your current or future relationships with your doctors. If you and your child decide to participate, your child is free to withdraw at any time without affecting those relationships.

Medical Condition
  • Migraine - Chronic
    • Study Drug
  • Atogepant
  • Placebo for Atogepant
    • Phase
    Phase 3
    Estimated Enrollment
    420 patients

    Participating in our Migraine Clinical Trials

    The HORIZON Study will last as short as several weeks or for up to 5 months. Eligible participants will receive the investigational study drug or the placebo (a pill designed not to have any biological effects on your body). All study-related visits, tests, and investigational study drug will be provided at no cost. If your child qualifies for the study, they may also receive compensation for time and travel. The study team will provide more information when they contact you.

    After completing the HORIZON study, your child may be eligible to participate in another voluntary study and receive the investigational study drug at no cost, for up to one year. Your child must qualify to participate in the voluntary open-label extension study. Please discuss this with your study doctor and the study team at the site.

    Study Participant Requirements

    Sex
    Female & Male
    Age
    12 - 17 Years

    Key Inclusion and Exclusion Criteria

    Participants must:

    • Be between the ages of 12 and 17 years
    • Weigh ≥ 40 kg (88 pounds) and < 135 kg (298 pounds)
    • Have a history of migraine for at least 6 months
    • Experience 15 or more headache days per month in the past three months

    Participants must not:

    • Have clinically significant hypertension
    • Have a history of migraine with partial vision loss (retinal migraine)
    • Have a history of cancer in the past five years
    • Have used cannabinoids or other THC derivatives (i.e., marijuana), or cannabidiol oil (systemically used) in the past 28 days
    • Have a history of clinically significant drug or alcohol abuse within the last 6 months

    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1. * During the last 28 days of the screening/baseline period, and as per eDiary: * Participant must have completed the eDiary for a minimum of 20 out of 28 days. * Participant has \>= 15 headache days. * Participant has \>= 8 migraine days.
    Exclusion Criteria:
    * Clinically significant hypertension per investigator's judgment. * History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.

    Study Locations

    Location
    Status
    Location
    Rehabilitation and Neurological Services /ID# 270782
    Huntsville, Alabama, United States, 35805
    Status
    Recruiting
    Location
    Preferred Research Partners - Fayetteville /ID# 270419
    Fayetteville, Arkansas, United States, 72703
    Status
    Completed
    Location
    Preferred Research Partner, Inc /ID# 270389
    Little Rock, Arkansas, United States, 72211
    Status
    Recruiting
    Location
    Advanced Research Center /ID# 270257
    Anaheim, California, United States, 92805
    Status
    Recruiting
    Location
    Neuro Pain Research Center /ID# 271048
    Fresno, California, United States, 93710
    Status
    Recruiting
    Location
    Accellacare - Long Beach /ID# 270398
    Long Beach, California, United States, 90807
    Status
    Recruiting
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    AGPT-US-0089-RM Version 1.0 Nov2025