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
Who is this study for? Patients with Brain Injury, Posttraumatic Headache
What treatments are being studied? Erenumab
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:
• 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
Locations
United States
North Carolina
Womack Army Medical Center - Fort Liberty
RECRUITING
Fort Bragg
Pennsylvania
University of Pittsburgh Concussion Research Laboratory
NOT_YET_RECRUITING
Pittsburgh
Texas
William Beaumont Army Medical Center
RECRUITING
El Paso
Washington
Madigan Army Medical Center
NOT_YET_RECRUITING
Tacoma
Contact Information
Primary
Amy Guthrie, RN
amy.guthrie.ctr@usuhs.edu
202-924-2729
Time Frame
Start Date: 2022-07-19
Estimated Completion Date: 2027-05-19
Participants
Target number of participants: 404
Treatments
Experimental: Active Drug
Erenumab administered once monthly via two 70-mg subcutaneous injections at 3 time points over a 12-week period.
Placebo_comparator: Placebo
Placebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period.
Authors
CAPT Diana Fu
Related Therapeutic Areas
Sponsors
Leads: Henry M. Jackson Foundation for the Advancement of Military Medicine