Post Traumatic Headache study: Eptinezumab
Official title Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
ClinicalTrials.gov ID: NCT07191145
What this study is testing
What is Eptinezumab?
This is an investigational medicine being studied to help prevent long-term headaches after a mild head injury. It is designed to block a specific protein in the body called CGRP that is linked to migraine-type headaches.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if a single dose of a new medication can stop acute headaches from becoming chronic after a mild head injury.
- Who it's for
- People who have had a mild head injury and are currently experiencing headaches that started within the last 8 weeks.
- What's involved
- Participants will receive one intravenous (IV) infusion of the study drug, eptinezumab, and will be monitored to track their headache symptoms over time.
- Time commitment
- The study involves an initial infusion and follow-up assessments to check headache levels three months after treatment.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.