Clinical trialNCT04567355Active, not recruitingPhase 2Interventional

Migraine Manager (R01)

SponsorChildren's Hospital Medical Center, CincinnatiEnrollment160MigraineMigraine Disorders

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Andrew Hershey, MD, PhD
Children's Hospital Medical Center, Cincinnati
Study Chair
clinicaltrials.gov ↗
James Peugh, PhD
Children's Hospital Medical Center, Cincinnati
Study Chair
clinicaltrials.gov ↗
Kevin Hommel, PhD
Children's Hospital Medical Center, Cincinnati
Principal Investigator
clinicaltrials.gov ↗
Lee Ritterband, MD
University of Virginia
Study Chair
clinicaltrials.gov ↗
Marielle Kabbouche-Samaha, MD
Children's Hospital Medical Center, Cincinnati
Study Chair
clinicaltrials.gov ↗
Scott Powers, PhD
Children's Hospital Medical Center, Cincinnati
Study Chair
clinicaltrials.gov ↗
Susan LeCates, MSN, FNP
Children's Hospital Medical Center, Cincinnati
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 10 Jun 2021
Primary completion: 31 May 2026
Completion: 30 Jun 2026
Last update posted: 2 Apr 2026
Registered enrollment: 160
Registry id: NCT04567355

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.