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

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ClinicalTrials.gov Identifier: NCT05049057
Recruitment Status : Recruiting
First Posted : September 17, 2021
Last Update Posted : December 21, 2023
Sponsor:
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

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).

Condition or disease Intervention/treatment Phase
Posttraumatic Headache Mild Traumatic Brain Injury Drug: Erenumab 140 Mg/mL Subcutaneous Solution Drug: Placebo Phase 2

Detailed Description:
Headache is recognized as one of the most common and disabling symptoms following head trauma. This study is designed to assess a calcitonin gene-related peptide (cGRP) monoclonal antibody (erenumab) for the preventive treatment of PTH based on the rationale that headache posttrauma is similar to migraine and is mediated by the activation of the trigeminal vascular system and subsequent release of cGRP. This study is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of erenumab 140 mg for the treatment of PTH in military service members and civilians with mTBI at military treatment facilities across the United States.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 19, 2022
Estimated Primary Completion Date : May 19, 2026
Estimated Study Completion Date : May 19, 2027


Arm Intervention/treatment
Experimental: Active Drug
Erenumab administered once monthly via two 70-mg subcutaneous injections at 3 time points over a 12-week period.
Drug: Erenumab 140 Mg/mL Subcutaneous Solution
Active erenumab delivered via subcutaneous injection.
Other Name: Aimovig

Placebo Comparator: Placebo
Placebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period.
Drug: Placebo
Placebo delivered via subcutaneous injection.




Primary Outcome Measures :
  1. Monthly Headache Days [ Time Frame: Week 8 to Week 12 ]
    Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary


Secondary Outcome Measures :
  1. Monthly Headache Days [ Time Frame: Week 0 to Week 12 ]
    Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary

  2. Monthly Headache Days [ Time Frame: Week 0 to Week 4 ]
    Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary

  3. Monthly Headache Days [ Time Frame: Week 0 to Week 8 ]
    Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary

  4. Adverse Events [ Time Frame: Week 0 to Week 12 ]
    Number of adverse events reported in erenumab group compared to placebo

  5. Return to Full Duty [ Time Frame: Week 0 to Week 12 ]
    Time to return to full activity as measured by the daily headache diary

  6. Concomitant Medications [ Time Frame: Week 0 to Week 12 ]
    Monthly use of medications for acute headache treatment

  7. Headache Days [ Time Frame: Week 0 to Week 12 ]
    Monthly headache days after early acute versus late acute administration of erenumab compared to placebo

  8. HPFID Activity [ Time Frame: Week 0 to Week 12 ]
    Monthly impact on everyday activity scores as measured by the Headache Physical Function Impact Diary Domain 1

  9. HPFID Physical Impairment [ Time Frame: Week 0 to Week 12 ]
    Monthly impact on physical impairment scores as measured by the Headache Physical Function Impact Diary Domain 2

  10. HIT-6 [ Time Frame: Week 0 to Week 12 ]
    Change from baseline in headache impact scores as measured by the Headache Impact Test

  11. PHQ-9 [ Time Frame: Week 0 to Week 12 ]
    Change from baseline in depressive symptoms after mTBI as measured by the self-report questionnaire, Patient Health Questionnaire-9, Total Score. Total scores range from a minimum of 0 to a maximum of 27, which are rated from minimal to severe levels of depression.

  12. ISI [ Time Frame: Week 0 to Week 12 ]
    Change from baseline in insomnia scores as measured by the Insomnia Severity Index


Other Outcome Measures:
  1. MSQ [ Time Frame: Week 0 to Week 12 ]
    Change from baseline in quality of life scores as measured by the Migraine-specific Quality of Life Questionnaire

  2. ASC-12 [ Time Frame: Week 0 to Week 12 ]
    Change from baseline in frequency of allodynia symptoms as measured by the Allodynia Symptom Checklist

  3. ANAM [ Time Frame: Week 0 to Week 12 ]
    Change from baseline in neuropsychological functions as assessed by the Automated Neuropsychological Assessment Metrics

  4. Function of Time [ Time Frame: 0-24 hours, 24-72 hours, 72-144 hours ]
    Effect of erenumab compared to placebo as a function of time from mTBI to first dose of erenumab as measured by the daily headache diary



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05049057


Contacts
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Contact: Amy Guthrie, RN 202-924-2729 amy.guthrie.ctr@usuhs.edu
Contact: Dutchabong Shaw 757-871-9557 dutchabong.shaw.ctr@usuhs.edu

Locations
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United States, North Carolina
Womack Army Medical Center - Fort Liberty Recruiting
Fort Bragg, North Carolina, United States, 28310
Contact: Jennifer Robles, RN    240-749-1042    jennifer.robles.ctr@usuhs.edu   
Contact: Alexandra Fraiser    240-749-4550    alexandra.fraiser.ctr@usuhs.edu   
Principal Investigator: CDR Katherine Demers         
United States, Pennsylvania
University of Pittsburgh Concussion Research Laboratory Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15203
Contact: Courtney Perry    412-904-1298    cap236@pitt.edu   
Principal Investigator: Anthony Kontos, MD         
United States, Texas
William Beaumont Army Medical Center Recruiting
El Paso, Texas, United States, 79918
Contact: Cecilia Valdovinos, NP       cecilia.valdovinos.ctr@usuhs.edu   
Principal Investigator: Sean Sebesta, MD         
United States, Washington
Madigan Army Medical Center Not yet recruiting
Tacoma, Washington, United States, 98431
Contact: Janel Cuevas    240-890-6518    janel.cuevas.ctr@usuhs.edu   
Principal Investigator: Melissa Belle, NP         
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Investigators
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Principal Investigator: David L Brody, MD, PhD Uniformed Services University of the Health Sciences
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Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT05049057    
Other Study ID Numbers: CNRM-CGRP-2020
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: December 21, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
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.

URL: http://fitbir.nih.gov/content/access-data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Post-Traumatic Headache
Headache
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pain
Neurologic Manifestations
Head Injuries, Closed
Wounds, Nonpenetrating
Headache Disorders, Secondary
Headache Disorders
Erenumab
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs