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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 is a Phase 2 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 132 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03472092
The ClinicalTrials.gov registry entry for NCT03472092 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT03472092 reports 0 study locations.
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.
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