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).
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.
Eligibility
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