NCT04567355CompletedPhase 2
Migraine Manager (R01)
Migraine Manager: An Individualized Self-Management Tool for Adolescents With Migraine (R01)
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 23 Sept 2020
- Start date
- 10 Jun 2021
- Primary completion date
- 6 May 2026
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Migraine
- NCT number
- NCT04567355
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 160
- From 10 Jun 2021 to the primary completion date, 6 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with a diagnosis of pervasive developmental disorder as determined by medical chart review
- Patients with a diagnosis of or serious mental illness (e.g., psychotic disorder) as determined by medical chart review
Who the study is looking for
- Confirmed diagnosis of migraine using current International Classification of Headache 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
Age in the registry: 11 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.