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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
404
Active erenumab delivered via subcutaneous injection.
Placebo delivered via subcutaneous injection.
Womack Army Medical Center - Fort Liberty
Fort Bragg, North Carolina, United States
RECRUITINGUniversity of Pittsburgh Concussion Research Laboratory
Pittsburgh, Pennsylvania, United States
NOT_YET_RECRUITINGWilliam Beaumont Army Medical Center
El Paso, Texas, United States
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Time frame: Week 8 to Week 12
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Time frame: Week 0 to Week 12
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Time frame: Week 0 to Week 4
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Time frame: Week 0 to Week 8
Adverse Events
Number of adverse events reported in erenumab group compared to placebo
Time frame: Week 0 to Week 12
Return to Full Duty
Time to return to full activity as measured by the daily headache diary
Time frame: Week 0 to Week 12
Concomitant Medications
Monthly use of medications for acute headache treatment
Time frame: Week 0 to Week 12
Headache Days
Monthly headache days after early acute versus late acute administration of erenumab compared to placebo
Time frame: Week 0 to Week 12
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Madigan Army Medical Center
Tacoma, Washington, United States
NOT_YET_RECRUITINGHPFID Activity
Monthly impact on everyday activity scores as measured by the Headache Physical Function Impact Diary Domain 1
Time frame: Week 0 to Week 12
HPFID Physical Impairment
Monthly impact on physical impairment scores as measured by the Headache Physical Function Impact Diary Domain 2
Time frame: Week 0 to Week 12
HIT-6
Change from baseline in headache impact scores as measured by the Headache Impact Test
Time frame: Week 0 to Week 12
PHQ-9
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.
Time frame: Week 0 to Week 12
ISI
Change from baseline in insomnia scores as measured by the Insomnia Severity Index
Time frame: Week 0 to Week 12