Multidisciplinary Translational Approach to Investigate Mechanisms Predictors & Prevention of Persistent PTH

Completed · Phase 2 · Has a placebo group

Conditions studied: Post-Traumatic Headache

In brief

This is a United States Department of Defense funded Focused Program study that aims to identify mechanisms and predictors for persistent of post-traumatic headache attributed to mild traumatic brain injury, and identify methods of preventing post-traumatic headache persistence. The objective of the clinical trial component of the Focused Program is to determine whether intervention with erenumab is an effective treatment for PTH attributed to mTBI.

Key facts

Study ID

NCT04098250

Run by

Mayo Clinic

People needed

6

Starts

2021-01-04

Expected to finish

2024-01-10

Last updated by the study team

2025-10-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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):
• Metal implants
• Aneurysm clips
• Severe claustrophobia
• Implanted electronic device
• Insulin or infusion pump
• Cochlear/otologic/ear implant
• Non-removable prosthesis
• Implanted shunts/catheters
• Certain intrauterine devices
• Tattooed makeup
• Body piercings that cannot be removed
• Metal fragments
• 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):
• Dental braces or other non-removable devices (e.g., retainers)

Where it is running

• Phoenix VA Health Care System — Phoenix, Arizona, United States
• Mayo Clinic — Phoenix, Arizona, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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