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Can a migraine drug stop Post-Concussion headaches?
NCT ID NCT04098250
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This small study tested whether the drug erenumab (Aimovig) can prevent persistent headaches after a mild traumatic brain injury. Six adults with recent post-traumatic headache were given either erenumab or a placebo. The goal was to see if the drug could reduce the number of moderate-to-severe headache days over 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Erenumab (Aimovig)
- What this could lead to
- If it works, this could point toward a treatment to prevent post-traumatic headaches from becoming chronic after a mild brain injury.
- What could go wrong
- This is a very small, early-phase trial with only 6 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are possible.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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6 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Jan 2024
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Have a diagnosis of acute PTH attributed to mild traumatic injury to the head as defined by the International Classification of Headache Disorders (ICHD-3). * PTH onset 7-56 days prior to the time of enrollment * Adults 18-70 years of age * Willing to be randomized to either of the two clinical trial treatment arms * Willing to maintain a headache diary * Willing and able to return for follow-up visits * 4 or more moderate or severe headache days during the 4-week run-in phase and an increase of at least 2 moderate to severe headache days compared to pre-TBI and at least a 30% increase * At least 80% compliant with diary keeping during the 4-week run-in phase (i.e., provides data on at least 80% of days) Exclusion Criteria: * Chronic headache (i.e., at least 15 headache days/month for more than 3 months) within 12 months prior to the mTBI that led to the current PTH, including PPTH, chronic migraine, medication overuse headache, new daily persistent headache, hemicrania continua, chronic tension-type headache * Diminished decision-making capacity that in the investigator's opinion would interfere with the person's ability to provide informed consent and complete study procedures * Started or changed dose of a headache preventive medication within the 3 months prior to screening * Use of onabotulinumtoxinA in the head, neck or face region within 6 months of screening * During the 6 months before screening, use of opioids or barbiturates on an average of at least 4 days per month * Subjects who underwent an intervention or used a device (e.g., nerve blocks, transcranial magnetic stimulation, vagal nerve stimulation, or electrical trigeminal nerve stimulation) for headache within 3 months of screening * History of major psychiatric disorder such as schizophrenia and bipolar disorder * History or evidence of any unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion * History of positive neuroimaging findings that indicate a moderate or severe TBI * Contraindications to magnetic resonance imaging, including, but not limited to (only an exclusion for patients participating in the brain MRI portion of this research): 1. Metal implants 2. Aneurysm clips 3. Severe claustrophobia 4. Implanted electronic device 5. Insulin or infusion pump 6. Cochlear/otologic/ear implant 7. Non-removable prosthesis 8. Implanted shunts/catheters 9. Certain intrauterine devices 10. Tattooed makeup 11. Body piercings that cannot be removed 12. Metal fragments 13. Wire sutures or metal staples * Factors that reduce MR image quality and interpretability (only an exclusion for patients participating in the brain MRI portion of this research): 1. Dental braces or other non-removable devices (e.g., retainers) 2. Prior brain surgery 3. Known brain MRI abnormality that in the investigator's opinion will significantly impact MRI data * Sensory disorders that in the investigator's opinion might affect perception of cutaneous thermal stimuli (e.g., peripheral neuropathy) (only an exclusion for patients participating in the neurophysiology studies) * Pregnancy * Breastfeeding * History of myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months prior to screening. * Not willing to use a reliable form of contraception (for women of childbearing potential) through 16 weeks after the last dose of erenumab. Acceptable methods of birth control include not having intercourse, hormonal birth control methods, intrauterine devices, surgical contraceptive methods, or two barrier methods (each partner must use a barrier method) with spermicide. A reliable form of contraception must be started prior to or at the time of starting the run-in phase. Not being of childbearing potential is defined as any woman who is post-menopausal by history, defined as: 1. At least 55 years of age with cessation of menses for 12 or more months; OR 2. Younger than 55 years of age but no spontaneous menses for at least 2 years; OR 3. Younger than 55 years of age and spontaneous menses within the past 1 year, but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels at least 40 IU/L) or postmenopausal estradiol level (less than 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved; OR 4. Underwent bilateral oophorectomy; OR 5. Underwent hysterectomy; OR 6. Underwent bilateral salpingectomy. * Currently or within 90 days prior to screening: received treatment in another drug study or an investigational device study * Has previously received any CGRP ligand or receptor targeted monoclonal antibody
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic
Phoenix, Arizona, 85054, United States
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Mayo Clinic
Jacksonville, Florida, 32224, United States
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Mayo Clinic
Rochester, Minnesota, 55901, United States
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Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
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Phoenix VA Health Care System
Phoenix, Arizona, 85012, United States
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