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Recruiting NCT05049057

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

Phase II Interventional Posttraumatic Headache Mild Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erenumab 140 Mg/mL Subcutaneous Solution, Placebo.
Who it may be relevant to
Registry conditions: Posttraumatic Headache, Mild Traumatic Brain Injury. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

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.

Primary outcome measures

  • Monthly Headache Days [Time frame: Week 8 to Week 12]
Secondary outcome measures (12)
  • Monthly Headache Days [Time frame: Week 0 to Week 12]
  • Monthly Headache Days [Time frame: Week 0 to Week 4]
  • Monthly Headache Days [Time frame: Week 0 to Week 8]
  • Adverse Events [Time frame: Week 0 to Week 12]
  • Return to Full Duty [Time frame: Week 0 to Week 12]
  • Concomitant Medications [Time frame: Week 0 to Week 12]
  • Headache Days [Time frame: Week 0 to Week 12]
  • HPFID Activity [Time frame: Week 0 to Week 12]
  • HPFID Physical Impairment [Time frame: Week 0 to Week 12]
  • HIT-6 [Time frame: Week 0 to Week 12]
  • PHQ-9 [Time frame: Week 0 to Week 12]
  • ISI [Time frame: Week 0 to Week 12]

Eligibility criteria

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:
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Womack Army Medical Center - Fort Liberty — Fort Bragg
  • University of Pittsburgh Concussion Research Laboratory — Pittsburgh
  • William Beaumont Army Medical Center — El Paso
  • Madigan Army Medical Center — Tacoma

Identifiers

NCT: NCT05049057 · CNRM-CGRP-2020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗