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Concussion headache drug trial stalls early

NCT ID NCT04226365

Symptom relief Sponsor: Lancaster General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether nortriptyline, a common antidepressant, could ease headaches after a concussion better than a placebo. It included teens aged 13-21 with recent head trauma. The trial was stopped early after enrolling only 8 people, so the results are not reliable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nortriptyline (Pamelor)
What this could lead to
If it works, this could point toward a faster way to ease headaches after a concussion.
What could go wrong
The trial was terminated early with only 8 participants, so results are very limited. It may not show a clear benefit or apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

8 people

The number who actually took part.

Started

Feb 2020

Finished

May 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 to 21 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Participants aged 13-21 years old 4. 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 5. Ability to take oral medication and be willing to adhere to the medication regimen 6. No loss of consciousness OR loss of consciousness \<30 minutes 7. Headache symptoms persisting ≥4 weeks post trauma 8. PCSHE score for headache + pressure in head + neck pain must be \> 3 9. After week 4 post-concussion at time of enrollment 10. Not currently receiving pharmacologic treatment for concussion asid from NSAIDs and acetaminophen Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Focal neurological deficits following injury 2. Any acute abnormality on Computed Tomography (if obtained) 3. History of known seizure disorder or moderate or severe TBI 4. Current uncontrolled psychiatric illness given the potential side effects of the study drug (at investigator discretion). 5. Current suicidal ideation as screened for on PHQ on intake 6. A personal history of Brugada syndrome 7. Known allergic reaction to nortriptyline 8. Current pregnancy 9. Positive COVID-19 test in prior 14 days

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Conditions

The condition(s) this trial relates to.

Brain Concussion Headache Post-Concussion Syndrome Post-Traumatic Headache traumatic brain injury traumatic encephalopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Concussion post syndrome Headaches posttraumatic Mild traumatic brain injury

Contacts and locations

Locations

  • Penn Medicine Lancaster General Health

    Lancaster, Pennsylvania, 17602, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.