Eptinezumab for Headache

This trial tests eptinezumab, a treatment for post-traumatic headaches (PTH) following mild head injury. The goal is to determine if a single dose of eptinezumab can reduce headaches and prevent them from becoming chronic. Suitable participants are those who have experienced these headaches for less than 8 weeks and exhibit migraine-like symptoms. As a Phase 3 trial, this treatment is in the final stage before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking therapy.

The trial does not specify if you need to stop all current medications, but you cannot use CGRP-related treatments or botulinum toxin for migraines within the last three months. Also, you should not use opioids or barbiturates for headaches more than 4 days a month.

Research has shown that eptinezumab is generally safe for people with headaches. One study reviewed six trials involving over 3,000 participants and found that side effects were no more common than with a placebo. Most side effects, when they occurred, appeared in the first month and were mild. Another study with 344 participants found that side effects occurred in only about 14% of headache cases, and these were mostly mild as well. Overall, people with migraines and similar conditions have tolerated eptinezumab well.¹²³⁴⁵

Eptinezumab is unique because it targets the calcitonin gene-related peptide (CGRP), a key player in headache pathways, offering a different approach compared to most standard treatments. Unlike oral medications that need to be taken frequently, eptinezumab is administered as a single intravenous infusion, which could mean less frequent dosing and more convenience for patients. Researchers are excited because this method might offer faster relief from post-traumatic headaches, potentially within just eight weeks, providing a promising option for those who don't respond to typical therapies.

Research has shown that eptinezumab, a medication that blocks the protein CGRP, may reduce the frequency and severity of migraines. In earlier studies, more than half of the patients experienced a significant reduction in the intensity of their migraine attacks after using eptinezumab. Some had fewer than four migraine days each month, and many reported an improved quality of life. For those with chronic migraines, eptinezumab significantly decreased migraine frequency, with up to 70% of patients having their monthly migraine days cut in half or more. In this trial, participants will receive either eptinezumab or a placebo to assess its effectiveness in treating post-traumatic headaches, particularly those resembling migraines.³⁴⁵⁶⁷