Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA (NCT02160535) | Clinical Trial Compass
TerminatedPhase 3
Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
Stopped: Study discontinued due to difficulty in enrolling eligible subjects
United States13 participantsStarted 2014-05
Plain-language summary
This study will provide evidence on whether the use of an FDA-approved drug therapy for the treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the head, or a fall, or a motor vehicle accident, or some other traumatic event.
Who can participate
Age range
18 Years – 60 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.
Inclusion Criteria:
* Diagnosis of mild traumatic brain injury (mTBI) within the past 15 months
* Suffer at least fifteen total headache days per month
* Ability to speak and read English
Exclusion Criteria:
* Subject with hypersensitivity reactions or other intolerance to OnabotulinumtoxinA
* Previous use of OnabotulinumtoxinA for treatment of headache
* Any medications commonly used as headache preventives started less than 3 months prior to enrollment
* Prior or current diagnosis of major psychiatric disorder or other central nervous system disorder
* Less than 80% compliance (recorded for less than 24 days) in the 30 day screening headache diary
* Subjects who are pregnant or trying to become pregnant within the timeframe of the study
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.