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Single infusion may prevent chronic headaches after concussion

NCT ID NCT07191145

Disease control Sponsor: Sunnybrook Health Sciences Centre 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study tests whether a single infusion of eptinezumab, given within 8 weeks of a mild brain injury, can reduce headache days and prevent short-term post-traumatic headaches from becoming long-term. About 80 adults with migraine-like post-traumatic headaches will receive either the drug or a placebo. The main goal is to see if the drug lowers the number of moderate-to-severe headache days 3 months after treatment.

What this could mean

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

Active substance
eptinezumab
What this could lead to
If it works, this could provide a quick, single-infusion treatment to prevent short-term post-traumatic headaches from becoming chronic and disabling.
What could go wrong
This is a small, early-phase trial with only 80 people. The drug may not work better than placebo, and side effects like fatigue or nausea could occur.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Meet diagnostic criteria for acute post-traumatic headache as per ICHD-3 criteria * Meet migraine screening questionnaire criteria (MSQ score ≥ 4) during at least one of the weekly screening calls * Within 8 weeks after onset of PTH \* Imaging is not required for inclusion * Negative human chorionic gonadotropin test before treatment, for female participants of childbearing potential who are not practicing medically appropriate methods of birth control (e.g., hormonal contraceptives, implants, injectables, intrauterine devices, intrauterine systems, etc.) Exclusion Criteria: * Diagnosis of moderate to severe TBI * History of mTBI within the past 5 years * Pre-existing chronic migraine and its subtypes, tension-type headache, trigeminal autonomic cephalalgias, cranial neuralgias, daily headache, diagnosis of another secondary headache disorder per ICHD-3 (except medication overuse headache) * Concurrent use of CGRP-related treatment or botulinum toxin within the last three month for migraine * Substance / opioids use disorder * Confounding chronic pain disorder / clinically significant pains * Concurrent major injuries (long bone, rib, and spinal fractures) or surgical intervention while in hospital on initial trauma * On-going litigation for current trauma * Pregnancy/breast-feeding * Uncontrolled psychiatric conditions (depression, PTSD, anxiety, functional neurological disorder) * Use of opioids/barbiturates for headaches (\> 4 days/month) * Hereditary fructose intolerance

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Conditions

The condition(s) this trial relates to.

migraine disorder Post-Traumatic Headache

As listed by the trial registrant

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

Post-traumatic headache

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

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