BridgeMD
New treatment option for Headache
Official title Responding With Evidence and Access for Childhood Headaches
ClinicalTrials.gov ID: NCT05889624
What this study is testing
What is Amitriptyline?
Amitriptyline is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for headache.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it.
- Time commitment: about 28 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 17
You may be able to join if
- Diagnosis: Migraine with or without aura that meets the International Classification of Headache Disorders (ICHD) criteria 5 or presentation of...
- Headache Frequency: 4 or more headache days based upon prospective headache diary of 28 days prior to randomization
- Amitriptyline Eligible: Site PI or medical staff determined participant to be eligible for clinical prescription of amitriptyline as a preventive...
- English fluency: Able to complete the study visits and questionnaires in English
You likely can't join if
- Current treatment includes amitriptyline and/or CBT specific to headache care
- Current prescribed preventive antimigraine medication within a period equivalent to \< 5 half-lives of that medication before entering the baseline...
- Current treatment with onabotulinumtoxinA (Botox) or CGRP-based monoclonal antibody medications for migraine prevention
- Youth who are pregnant
- Report of current or ongoing suicidal thoughts. Suicide attempt within the past six months. History of bipolar disorder, prolonged QT, or...
- Any and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Wilmington, Delaware, United States
- Atlanta, Georgia, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- Amherst, New York, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
- Austin, Texas, United States
- Huntington, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 28 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; San Francisco, California, United States; Aurora, Colorado, United States; Wilmington, Delaware, United States; Atlanta, Georgia, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.