Evaluating Erenumab 140 mg for Treating Acute Post-Traumatic Headache in Military and Civilian Adults with Mild Traumatic Brain Injury Randomized, Double-Blind, Placebo-Controlled 12-Week Study with 4-Week Safety Follow-Up

What this Trial Is About

Researchers are evaluating the effects and safety of erenumab, a calcitonin gene-related peptide cGRP monoclonal antibody, compared to placebo for treating acute posttraumatic headache PTH in both military service members and civilians who have experienced mild traumatic brain injury mTBI. The study is designed to explore preventive treatment based on the idea that posttrauma headache resembles migraine and involves activation of the trigeminal vascular system and cGRP release. This is a randomized, double-blind, placebo-controlled Phase 2 study conducted at military treatment facilities across the United States. Participants receive either erenumab 140 mg or placebo via subcutaneous injections. The active drug is administered as two 70-mg injections once monthly at three time points over a 12-week period. The placebo group receives two subcutaneous injections on the same schedule. After the 12-week treatment phase, there is a 4-week open-label safety extension where all participants are monitored. During the study, participants will be monitored for headache frequency and safety from week 0 to week 12, with the primary outcome measuring monthly headache days between weeks 8 and 12. Secondary outcomes include headache days over various intervals, adverse events, return to full duty status, medication use, physical impairment, and assessments of headache impact, depression, and insomnia. Participants must be able to provide informed consent and have access to standard care for PTH and TBI. The total participation duration includes treatment and safety monitoring over approximately 16 weeks.

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