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
Henry M. Jackson Foundation for the Advancement of Military Medicine
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).
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 c…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugErenumab 140 Mg/mL Subcutaneous Solution
Active erenumab delivered via subcutaneous injection.
- DrugPlacebo
Placebo delivered via subcutaneous injection.
Locations (4)
- Womack Army Medical Center - Fort LibertyFort Bragg, North Carolina
- University of Pittsburgh Concussion Research LaboratoryPittsburgh, Pennsylvania
- William Beaumont Army Medical CenterEl Paso, Texas
- Madigan Army Medical CenterTacoma, Washington