Multidisciplinary Translational Approach to Investigate Mechanisms Predictors & Prevention of Per… (NCT04098250) | Clinical Trial Compass
CompletedPhase 2
Multidisciplinary Translational Approach to Investigate Mechanisms Predictors & Prevention of Persistent PTH
United States6 participantsStarted 2021-01-04
Plain-language summary
This is a United States Department of Defense funded Focused Program study that aims to identify mechanisms and predictors for persistent of post-traumatic headache attributed to mild traumatic brain injury, and identify methods of preventing post-traumatic headache persistence.
The objective of the clinical trial component of the Focused Program is to determine whether intervention with erenumab is an effective treatment for PTH attributed to mTBI.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Metal implants
. Aneurysm clips
. Severe claustrophobia
. Implanted electronic device
. Insulin or infusion pump
. Cochlear/otologic/ear implant
. Non-removable prosthesis
. Implanted shunts/catheters
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focused on understanding the mechanisms and predictors of persistent post-traumatic headache — since it's now completed, has any data been published that my doctor could review to help understand what factors put someone at higher risk for their headache becoming long-lasting?
2The trial was measuring changes in the number of days with moderate-to-severe headaches — based on what was studied here, are there any prevention strategies or early interventions my doctor thinks could reduce the chance of my post-traumatic headache becoming chronic?
3Since this was a Phase 2 trial, what does that mean for how much we actually know about the safety and effectiveness of any approaches being tested, and should I be looking at more advanced trials or standard treatments instead?
4The trial used a multidisciplinary translational approach — does my doctor think I should be seeing specialists beyond just a neurologist, such as a physical therapist or psychologist, as part of managing my post-traumatic headache?
5Now that this trial is completed, are there follow-up or related trials that grew out of this research that my doctor thinks might be relevant to my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Number of Days Experiencing Moderate-to-Severe Headaches
Timeframe: Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported