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

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 19, 2026

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.

Interventions

  • Drug: Erenumab 140 Mg/mL Subcutaneous Solution
    • Active erenumab delivered via subcutaneous injection.
  • Drug: Placebo
    • Placebo delivered via subcutaneous injection.

Arms, Groups and Cohorts

  • Experimental: Active Drug
    • Erenumab administered once monthly via two 70-mg subcutaneous injections at 3 time points over a 12-week period.
  • Placebo Comparator: Placebo
    • Placebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period.

Clinical Trial Outcome Measures

Primary Measures

  • Monthly Headache Days
    • Time Frame: Week 8 to Week 12
    • Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary

Secondary Measures

  • Monthly Headache Days
    • Time Frame: Week 0 to Week 12
    • Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
  • Monthly Headache Days
    • Time Frame: Week 0 to Week 4
    • Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
  • Monthly Headache Days
    • Time Frame: Week 0 to Week 8
    • Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
  • Adverse Events
    • Time Frame: Week 0 to Week 12
    • Number of adverse events reported in erenumab group compared to placebo
  • Return to Full Duty
    • Time Frame: Week 0 to Week 12
    • Time to return to full activity as measured by the daily headache diary
  • Concomitant Medications
    • Time Frame: Week 0 to Week 12
    • Monthly use of medications for acute headache treatment
  • Headache Days
    • Time Frame: Week 0 to Week 12
    • Monthly headache days after early acute versus late acute administration of erenumab compared to placebo
  • HPFID Activity
    • Time Frame: Week 0 to Week 12
    • Monthly impact on everyday activity scores as measured by the Headache Physical Function Impact Diary Domain 1
  • HPFID Physical Impairment
    • Time Frame: Week 0 to Week 12
    • Monthly impact on physical impairment scores as measured by the Headache Physical Function Impact Diary Domain 2
  • HIT-6
    • Time Frame: Week 0 to Week 12
    • Change from baseline in headache impact scores as measured by the Headache Impact Test
  • PHQ-9
    • Time Frame: Week 0 to Week 12
    • Change from baseline in depressive symptoms after mTBI as measured by the self-report questionnaire, Patient Health Questionnaire-9, Total Score. Total scores range from a minimum of 0 to a maximum of 27, which are rated from minimal to severe levels of depression.
  • ISI
    • Time Frame: Week 0 to Week 12
    • Change from baseline in insomnia scores as measured by the Insomnia Severity Index

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Henry M. Jackson Foundation for the Advancement of Military Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David L Brody, MD, PhD, Principal Investigator, Uniformed Services University of the Health Sciences
  • Overall Contact(s)
    • Amy Guthrie, RN, 202-924-2729, amy.guthrie.ctr@usuhs.edu

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