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NCT04567355 · ClinicalTrials.gov registry record · Phase 2
Migraine Manager (R01)
A Phase 2 study of Migraine and Migraine Disorders, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT04567355: Recruiting Phase 2 study of Migraine and Migraine Disorders, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04567355 is a Phase 2 study of Migraine and Migraine Disorders that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 160 participants, below the 357-participant average among 102 other Migraine trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04567355, a Phase 2 study of Migraine and Migraine Disorders, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Change in number of days with a headache
Conditions Studied
Interventions
- BEHAVIORAL Migraine Manager
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2021-06-10 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What NCT04567355 shows while recruiting
NCT04567355 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 357-participant average among 102 other Migraine trials with a reported enrollment target (55% lower).
The record links to 2 conditions, with Migraine appearing as the primary indexed condition, and to 1 intervention - of which Migraine Manager is the first listed.
NCT04567355 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04567355 about?
NCT04567355 is a clinical study titled "Migraine Manager (R01)". 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 (ag...
What is the current status of trial NCT04567355?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2021-06-10. Estimated completion is 2026-06-30.
What conditions does trial NCT04567355 study?
This clinical trial studies the following conditions: Migraine, Migraine Disorders.
What interventions are being tested in trial NCT04567355?
The interventions under investigation include: Migraine Manager (BEHAVIORAL).
Who is sponsoring clinical trial NCT04567355?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04567355 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Migraine
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04567355's enrollment target sits among peer trials
160 47th of 102 higher than 56 of 102 other Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Migraine trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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