Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Erenumab 140 Mg/mL Subcutaneous Solution
- Placebo
Treatment groups
404 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov