Stopped: The study was stopped prematurely due to a low enrollment rate.
United States8 participantsStarted 2020-02-15
Plain-language summary
This is a randomized, placebo-controlled, double-blinded trial in which subjects with a post concussive headache meeting inclusion criterion will be assigned to one of two treatment groups: placebo or nortriptyline. Each group will be evaluated at week 0 and again each week for the next 4 weeks of treatment with a concussion survey that rates their symptoms. At the end of 4 weeks the study will be unblinded. It is hypothesized that the addition of nortriptyline to the standard headache treatments will result in more rapid decrease of symptom score than with placebo.
Who can participate
Age range
13 Years – 21 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
. Provision of signed and dated informed consent form
. Stated willingness to comply with all study procedures and availability for the duration of the study
. Participants aged 13-21 years old
. In good general health as evidenced by medical history and diagnosed with recent head trauma meeting ICHD-3 criteria for acute posttraumatic headache with symptom onset \< 7 days from trauma
. Ability to take oral medication and be willing to adhere to the medication regimen
. No loss of consciousness OR loss of consciousness \<30 minutes
. Headache symptoms persisting ≥4 weeks post trauma
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 was terminated before it finished — can you tell me why it was stopped early, and whether that affects what we can learn from the data it did collect about treating my child's post-concussion symptoms?
2Since this study was specifically measuring post-concussive symptoms using the Post-Concussive Symptom Inventory, are there completed trials or published studies using that same tool that might give us better guidance on managing my child's headaches and other lingering symptoms?
3This was a Phase 4 trial, which means the treatment being studied was already approved — can you tell me what that treatment was and whether it's something you'd consider for my child's post-concussion care right now, outside of a trial?
4Given that this trial focused on pediatric concussion outcomes, are there other currently active studies enrolling children with post-concussion syndrome or post-traumatic headaches that my child's care team thinks would be worth looking into?
5Since the trial is no longer recruiting, what approach are you currently recommending for kids with persistent post-concussion symptoms, and how does that compare to whatever this study was testing?
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.