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).
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
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
Parallel
Erenumab 140 Mg/mL Subcutaneous Solution
DrugActive erenumab delivered via subcutaneous injection.
Placebo
DrugPlacebo delivered via subcutaneous injection.
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Adverse Events
Number of adverse events reported in erenumab group compared to placebo
MSQ
Change from baseline in quality of life scores as measured by the Migraine-specific Quality of Life Questionnaire
ASC-12
Change from baseline in frequency of allodynia symptoms as measured by the Allodynia Symptom Checklist
ANAM
Change from baseline in neuropsychological functions as assessed by the Automated Neuropsychological Assessment Metrics
Function of Time
Effect of erenumab compared to placebo as a function of time from mTBI to first dose of erenumab as measured by the daily headache diary
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