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 range13 Years – 21 Years
SexALL
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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
✓. PCSHE score for headache + pressure in head + neck pain must be \> 3