Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI

• Status: Not yet recruiting
• Trial end date: 2027-12-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Treatments: Erenumab

Criteria

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:

1. abnormal structural imaging

2. loss of consciousness for >30 minutes

3. 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