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
1 other identifier
interventional
404
1 country
4
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2022
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2021
CompletedFirst Posted
Study publicly available on registry
September 17, 2021
CompletedStudy Start
First participant enrolled
July 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2027
ExpectedFebruary 22, 2024
February 1, 2024
3.8 years
July 26, 2021
February 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Week 8 to Week 12
Secondary Outcomes (12)
Monthly Headache Days
Week 0 to Week 12
Monthly Headache Days
Week 0 to Week 4
Monthly Headache Days
Week 0 to Week 8
Adverse Events
Week 0 to Week 12
Return to Full Duty
Week 0 to Week 12
- +7 more secondary outcomes
Other Outcomes (4)
MSQ
Week 0 to Week 12
ASC-12
Week 0 to Week 12
ANAM
Week 0 to Week 12
- +1 more other outcomes
Study Arms (2)
Active Drug
EXPERIMENTALErenumab administered once monthly via two 70-mg subcutaneous injections at 3 time points over a 12-week period.
Placebo
PLACEBO COMPARATORPlacebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period.
Interventions
Active erenumab delivered via subcutaneous injection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Womack Army Medical Center - Fort Liberty
Fort Bragg, North Carolina, 28310, United States
University of Pittsburgh Concussion Research Laboratory
Pittsburgh, Pennsylvania, 15203, United States
William Beaumont Army Medical Center
El Paso, Texas, 79918, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David L Brody, MD, PhD
Uniformed Services University of the Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2021
First Posted
September 17, 2021
Study Start
July 19, 2022
Primary Completion
May 19, 2026
Study Completion (Estimated)
May 19, 2027
Last Updated
February 22, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After study completion, data sets will be de-identified and shared with the repositories. De-identified data sets will be stored in the repositories indefinitely.
- Access Criteria
- Access to the CNRM Data Repository will be determined b the CNRM Data Quality, Access, and Publication Committee. Investigators requesting access to the data will provide a list of investigators and collaborators who will have access to the data, documentation of Ethical Conduct of Research and Human Participants Protection Training, and documentation of Institutional Review Board Approval of the research project. Access to FITBIR will follow FITBIR Access Criteria.
Identifier-free participant data sets will be shared with the Uniformed Services University Center for Neuroscience and Regenerative Medicine Data Repository. Identifier-free data sets may also be shared with the Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Repository