Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI
NCT ID: NCT05049057
Last Updated: 2024-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
404 participants
INTERVENTIONAL
2022-07-19
2027-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Drug
Erenumab administered once monthly via two 70-mg subcutaneous injections at 3 time points over a 12-week period.
Erenumab 140 Mg/mL Subcutaneous Solution
Active erenumab delivered via subcutaneous injection.
Placebo
Placebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period.
Placebo
Placebo delivered via subcutaneous injection.
Interventions
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Erenumab 140 Mg/mL Subcutaneous Solution
Active erenumab delivered via subcutaneous injection.
Placebo
Placebo delivered via subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
50 Years
ALL
No
Sponsors
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Henry M. Jackson Foundation for the Advancement of Military Medicine
OTHER
Responsible Party
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Principal Investigators
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David L Brody, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Uniformed Services University of the Health Sciences
Locations
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Womack Army Medical Center - Fort Liberty
Fort Bragg, North Carolina, United States
University of Pittsburgh Concussion Research Laboratory
Pittsburgh, Pennsylvania, United States
William Beaumont Army Medical Center
El Paso, Texas, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CNRM-CGRP-2020
Identifier Type: -
Identifier Source: org_study_id
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