Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI
NCT05049057 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 404
Last updated 2024-02-22
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).
Conditions
- Posttraumatic Headache
- Mild Traumatic Brain Injury
Interventions
- DRUG
-
Erenumab 140 Mg/mL Subcutaneous Solution
Active erenumab delivered via subcutaneous injection.
- DRUG
-
Placebo delivered via subcutaneous injection.
Sponsors & Collaborators
-
Henry M. Jackson Foundation for the Advancement of Military Medicine
lead OTHER
Principal Investigators
-
David L Brody, MD, PhD · Uniformed Services University of the Health Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-19
- Primary Completion
- 2026-05-19
- Completion
- 2027-05-19
Countries
- United States
Study Locations
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