NCT05049057

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

Treatment of Acute Post-Traumatic Headache With Erenumab 140 mg, Military Service Members and Civilians With Mild TBI: A Randomized, Double Blind, Placebo Controlled, Multicenter 12-week Duration Study Followed by a 4-week Open-Label Safety Extension

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 404 (estimated)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (PTH) in military service members and civilians with mild traumatic brain injury (mTBI).

Detailed description

Headache is recognized as one of the most common and disabling symptoms following head trauma. This study is designed to assess a calcitonin gene-related peptide (cGRP) monoclonal antibody (erenumab) for the preventive treatment of PTH based on the rationale that headache posttrauma is similar to migraine and is mediated by the activation of the trigeminal vascular system and subsequent release of cGRP. This study is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of erenumab 140 mg for the treatment of PTH in military service members and civilians with mTBI at military treatment facilities across the United States.

Conditions

• Posttraumatic Headache
• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	Erenumab 140 Mg/mL Subcutaneous Solution	Active erenumab delivered via subcutaneous injection.
DRUG	Placebo	Placebo delivered via subcutaneous injection.

Timeline

• Start date: 2022-07-19
• Primary completion: 2026-05-19
• Completion: 2027-05-19
• First posted: 2021-09-17
• Last updated: 2024-02-22

Locations

4 sites across 1 country: United States