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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

abnormal structural imaging

loss of consciousness for >30 minutes

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

Trial design

Treatments tested in this trial

  • Erenumab 140 Mg/mL Subcutaneous Solution
  • Placebo

Treatment groups

404 Participants
are divided into 2 treatment groups

Locations

4
Womack Army Medical Center - Fort Liberty28310, Fort BraggNorth Carolina, United States
University of Pittsburgh Concussion Research Laboratory15203, PittsburghPennsylvania, United States
William Beaumont Army Medical Center79918, El PasoTexas, United States
Madigan Army Medical Center98431, TacomaWashington, United States

Sponsors and collaborators

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead sponsor