Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI
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
404 participants
Jul 19, 2022
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria6
- 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 Criteria5
- 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
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Interventions
Active erenumab delivered via subcutaneous injection.
Placebo delivered via subcutaneous injection.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05049057