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Erenumab for Posttraumatic Headache after Mild Traumatic Brain Injury

This study is testing a medication called erenumab (140 mg/mL subcutaneous solution) against a placebo (an inactive substance) to see if it can help treat acute posttraumatic headache (PTH) in military service members and civilians. Erenumab is a monoclonal antibody, which is a type of protein that can block specific targets in the body. Researchers believe PTH may be similar to migraine, and erenumab works by targeting a specific pathway involved in headache. You might be able to join if you are between 18 and 50 years old, have experienced a mild traumatic brain injury (mTBI) and PTH within the last 7 days, and have a personal healthcare provider. The main goal is to see how many headache days participants have each month, measured between Week 8 and Week 12. The study's current status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either erenumab or a placebo, and neither you nor your doctor will know which you are receiving. It plans to enroll 404 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured between Week 8 and Week 12, suggesting follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05049057

Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI

Recruiting
PHASE2Ages 18–50InterventionalTreatment
Henry M. Jackson Foundation for the Advancement of Military Medicine
~404 participants
Updated 2024-02-22 on ClinicalTrials.gov
What's tested:Erenumab 140 Mg/mL Subcutaneous SolutionPlacebo

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Monthly Headache Days
Measured over Week 8 to Week 12

Conditions

Posttraumatic Headache
Mild Traumatic Brain Injury

Explore related trials

ConcussionPosttraumatic headache

Where it's being run

4 sites across 4 states
North Carolina1
Pennsylvania1
Texas1
Washington1

Study leadership

  • David L Brody, MD, PhD · PRINCIPAL_INVESTIGATOR · Uniformed Services University of the Health Sciences

Who to contact

Amy Guthrie, RN
[email protected]
202-924-2729
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female ≥18 and ≤50 years of age
mTBI from any cause including impact, rotational acceleration, blast, or a combination, has occurred within the prior 7 days
PTH has occurred within the prior 7 days
Able to provide informed consent
Likely to stay in the same geographical area for the duration of study
Has a personal health care provider for standard of care PTH and TBI, including education, diagnostic procedures including neuroimaging and treatment, as deemed clinically indicated by the health care provider

Exclusion

Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury:
Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury

What this trial measures

  • Monthly Headache DaysWeek 8 to Week 12

    Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary