Migraine Manager (R01)

Last updated: July 3, 2025
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Active - Recruiting

Phase

2

Condition

Pain

Oral Facial Pain

Chronic Pain

Treatment

Migraine Manager

Clinical Study ID

NCT04567355
MM R01
R01NR019426
  • Ages 11-17
  • All Genders

Study Summary

The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache outcomes compared to an attention control intervention in adolescents with migraines. We will conduct a randomized clinical trial to compare a sample of 80 youth (ages 11 to 17) with migraine receiving the online tailored adherence intervention to 80 youth in an attention control group. We will test whether adherence to healthy habit (hydration, regular meals, exercise, sleep) recommendations serves as a mechanism for improved headache outcomes. Clinically meaningful outcomes will be assessed by reliable, valid, and sensitive measures. The primary outcome (i.e., number of headache days) will be assessed via online daily diary pre- and post-intervention, with additional follow-up at 3, 6, 9, and 12 months. Secondary outcomes include health-related quality of life and migraine disability.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of migraine using current International Classification ofHeadache Disorders Criteria (ICHD-3) for migraine with or without aura

  • Frequency of 8 or more headaches per month

  • Access to the internet whether public (e.g., library) or private (e.g., home,personal)

  • English fluency for patient and caregiver

Exclusion

Exclusion Criteria:

  • Patients with a diagnosis of pervasive developmental disorder as determined bymedical chart review

  • Patients with a diagnosis of or serious mental illness (e.g., psychotic disorder) asdetermined by medical chart review

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Migraine Manager
Phase: 2
Study Start date:
June 10, 2021
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

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