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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04567355
The ClinicalTrials.gov registry entry for NCT04567355 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 357-participant average among 102 other Migraine trials with a reported enrollment target (55% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.