Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04567355 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Migraine Manager (R01)

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Children's Hospital Medical Center, Cincinnati to Children's Hospital Medical Center, Cincinnati Trial completed · Study completion date changed from estimate of Jun 30, 2026 to May 6, 2026 · Eligibility criteria expanded, about 6 words · 2 more Show 5 more changesShow less
    • Trial completed
    • Study completion date changed from estimate of Jun 30, 2026 to May 6, 2026
    • Eligibility criteria expanded, about 6 words
    • Site details revised
    • Collaborators expanded, about 6 words
  2. Trial status: Recruiting to Active, Not Recruiting Site details revisedv11 Show 1 more changeShow less
    • Site details revised
  3. Primary completion date: Apr 1, 2025 to May 31, 2026 Completion date: May 31, 2025 to Jun 30, 2026v10 Show 1 more changeShow less
    • Completion date: May 31, 2025 to Jun 30, 2026
  4. Phase: Not applicable to Phase 2v9
  5. Primary completion date: Mar 1, 2025 to Apr 1, 2025 Completion date: Apr 30, 2025 to May 31, 2025v8 Show 1 more changeShow less
    • Completion date: Apr 30, 2025 to May 31, 2025
Show 6 earlier versionsHide 6 earlier versions
  1. Site details revisedv7
  2. Re-verified, no change to tracked fieldsv6
  3. Completion date: May 1, 2025 to Apr 30, 2025v5
  4. Start date: May 10, 2021 to Jun 10, 2021v4
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary completion date: Sep 2024 to Mar 1, 2025 · Completion date: Sep 2024 to May 1, 2025 · 1 morev3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Sep 2024 to Mar 1, 2025
    • Completion date: Sep 2024 to May 1, 2025
    • Start date changed from estimate of Mar 2021 to May 10, 2021
  6. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04567355
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: National Institute of Nursing Research (NINR)
Conditions Migraine, Migraine Disorders
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov