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NCT03472092 · ClinicalTrials.gov registry record · Phase 2
Mind and Body Approaches to Pain Reduction in Youth With Migraine
A Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
NCT03472092: Completed Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03472092 is a Phase 2 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 132 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03472092, a Phase 2 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
Study Summary
The overarching objective of this protocol is to identify and understand the neural and pain processing mechanisms by which youth with migraine improve in response to preventive treatment. The study design of this mechanistic investigation includes functional magnetic resonance imaging (fMRI), daily headache diaries, assessment of conditioned pain modulation via quantitative sensory testing, and validated psychometric assessments before and after the delivery of one of five treatments over an 8 week period \[cognitive behavioral therapy (CBT), biofeedback-assisted relaxation training (BART) and cognitive reappraisal (CR) training, amitriptyline, and placebo\]. We are examining both distinct and common pathways that may help explain the response to various preventive treatments, as well as potential predictors of outcome.
Primary Outcome
For each study group, changes in distinct neural mechanisms of the brain will be compared to between baseline and post treatment (8 weeks). For each study group, the primary endpoint will be examine changes in brain connectivity and activation.
Interventions
- DRUG Placebo
- BEHAVIORAL Cognitive Behavioral Therapy (CBT)
- DRUG Amitriptyline
- BEHAVIORAL Biofeedback-Assisted Relaxation Training (BART)
- BEHAVIORAL Cognitive Reappraisal Training (CR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2018-10-02 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 2 |
What the finished NCT03472092 record still lists
NCT03472092 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT03472092 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03472092 about?
NCT03472092 is a clinical study titled "Mind and Body Approaches to Pain Reduction in Youth With Migraine". The overarching objective of this protocol is to identify and understand the neural and pain processing mechanisms by which youth with migraine improve in response to preventive treatment. The study design of this mechanistic investigation includes functional magnetic resonance imaging (fMRI), daily...
What is the current status of trial NCT03472092?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2018-10-02. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT03472092?
The interventions under investigation include: Placebo (DRUG), Cognitive Behavioral Therapy (CBT) (BEHAVIORAL), Amitriptyline (DRUG), Biofeedback-Assisted Relaxation Training (BART) (BEHAVIORAL), Cognitive Reappraisal Training (CR) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03472092?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03472092's enrollment target sits among peer trials
132 539th of 2000 higher than 1,460 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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