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NCT05049057PHASE2Recruiting

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

Henry M. Jackson Foundation for the Advancement of Military Medicine

Start Date

7/19/2022

Completion Date

5/19/2027

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.

Eligibility Criteria

Age Range: 18 years to 50 years

Inclusion Criteria: * 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 Criteria: * Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury: 1. abnormal structural imaging 2. loss of consciousness for \>30 minutes 3. alteration of consciousness/mental state for \>24 hours 3. post-traumatic amnesia for \>1 day * Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury

Interventions

DRUG

Erenumab 140 Mg/mL Subcutaneous Solution

DRUG

Placebo

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Conditions

Posttraumatic HeadacheMild Traumatic Brain Injury

Locations

Womack Army Medical Center - Fort Liberty

Fort Bragg, North Carolina 28310

United States

University of Pittsburgh Concussion Research Laboratory

Pittsburgh, Pennsylvania 15203

United States

William Beaumont Army Medical Center

El Paso, Texas 79918

United States

Madigan Army Medical Center

Tacoma, Washington 98431

United States