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 Episodic Migraine in Pediatric Subjects 6 to 17 Years of Age

Study Identifier
M21-201
CT.gov Identifier
NCT05711394
EudraCT Identifier
Not available
EUCTIS ID
2022-501100-94-00
For general inquiries, please contact

844-663-3742 or [email protected]

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Study Details

The KALEIDOSCOPE research study is for children of 6 to 17 years with episodic migraine. Migraine is a severe, chronic neurological disease characterized by attacks of moderate-to-severe headache, sensory disturbances, and other symptoms. Migraine represents a major cause of disability in adults and in children.

The KALEIDOSCOPE Study is evaluating an investigational product called atogepant for the prevention of migraine in children. The investigational treatment is currently approved to prevent migraines in adults. Its safety and effectiveness in children are 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 - Episodic
    • Study Drug
  • Atogepant
  • Placebo-Matching Atogepant
    • Phase
    Phase 3
    Estimated Enrollment
    450 patients

    Participating in our Migraine Clinical Trials

    If your child has migraine, they may qualify for the KALEIDOSCOPE Study. The study will include about 7 visits to a study site within a close travel distance from your home. Your child will receive the investigational product or a placebo (that is, a substance with no medical effect), which can both be taken by mouth. The study team will provide more information when they contact you.

    Your child’s participation may be as short as several weeks or for up to 4 months. After completing the KALEIDOSCOPE study, you may be eligible to participate in a voluntary 1-year, open-label extension study at no cost. Volunteers who qualify to take part in the study may receive compensation for time and travel. 

    Study Participant Requirements

    Sex
    Female & Male
    Age
    6 - 17 Years

    Key Inclusion and Exclusion Criteria

    Participants must:

    • Be between the ages of 6-11 years old
    • Have been diagnosed with migraine for at least 6 months
    • Experience between 4 and 14 migraine and less than 15 headache days per month
    • Be able to swallow or can learn to swallow a pill

    Participants must not:

    • Have a current diagnosis of chronic migraine
    • Have clinically significant hypertension
    • Have a history of gastrointestinal disease that could affect drug absorption (e.g., inflammatory bowel disease)
    • Be concurrently taking another migraine prevention treatment (e.g., topiramate, propranolol)

    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Weight is \>= 20 kg (44 lbs) and \< 135 kg (298 lbs). * History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months. * Participant has to have 4 to 14 migraine days and \< 15 headache days in the 28-day baseline period per eDiary. * To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine (consistent with a diagnosis according to the ICHD-3 \[2018\]) and per investigator judgment is appropriate to receive preventive treatment for migraine.
    Exclusion Criteria:
    * History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018). * Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018). * Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).

    Study Locations

    Location
    Status
    Location
    Rehabilitation & Neurological Services /ID# 248517
    Huntsville, Alabama, United States, 35805-4046
    Status
    Recruiting
    Location
    The Center for Clinical Trials - Saraland /ID# 271604
    Saraland, Alabama, United States, 36571
    Status
    Recruiting
    Location
    Preferred Research Partners /ID# 249729
    Little Rock, Arkansas, United States, 72211
    Status
    Recruiting
    Location
    Preferred Research Partners /ID# 270406
    Little Rock, Arkansas, United States, 72211
    Status
    Completed
    Location
    Advanced Research Center /ID# 251381
    Anaheim, California, United States, 92805
    Status
    Recruiting
    Location
    Alliance for Research Alliance for Wellness /ID# 248521
    Long Beach, California, United States, 90807
    Status
    Recruiting
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    AGPT-US-0088-RM Version 1.0 Oct2025