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Atogepant for the Treatment of Pediatric Participants with Episodic Migraine

Pediatric | Migraine | Headache | Clinical Trial

Atogepant has been approved to treat episodic migraine in adults by Health Canada but has not been studied or approved in children. The purpose of this study is to see if atogepant is effective and safe for the treatment of episodic migraine in children. This research study plans to include 450 participants with episodic migraine.

Participants will receive one of 3 treatments: low dose atogepant, high dose atogepant, or placebo. The study medication is given as a pill that is taken daily. Participants and the study doctor will not know whether they are receiving atogepant or placebo.

Participants will track their headaches in an eDiary. There will be 7 visits in total and these will include questionnaires, bloodwork, and ECG.

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Participation Requirements

  • Sex:

    Female, Any, Male

  • Eligible Ages:

    6 to 17

Participation Criteria

Inclusion Criteria:
- age 6-17
- Weight ≥ 20 kg (44 lbs) and < 135 kg (298 lbs)
- able to swallow pills
- able to fill out daily electronic headache diary
- diagnosed with episodic migraine (less than 15 headache days per month)
- able to attend 7 in person study visits at the Stollery Children's Hospital
- current or past use of at least 1 prescription or non-prescription medication to treat migraine
Exclusion Criteria:
- drug or alcohol abuse or dependency
- diagnosis of hemiplegic migraine, retinal migraine, chronic daily headache, or cluster headaches
- diagnosis of chronic migraine (more than 15 headache days per month)
- other significant medical diagnoses, including chronic gastrointestinal conditions
- history of self-harm in the last 6 months
- history of adverse reaction or sensitivity to CGRP medications
- pregnant or plan to become pregnant
- history of hepatitis B, hepatitis C, or HIV

Study Location

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Meghan Freer

[email protected]
780-248-5605
Primary Contact

Kirstie McDermott

[email protected]
780-248-5603
Study Sponsored By
University of Alberta
Participants Required
More Information
Study ID: Pro00128987