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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 : February 22, 2024
Sponsor:
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

Tracking Information
First Submitted Date  ICMJE July 26, 2021
First Posted Date  ICMJE September 17, 2021
Last Update Posted Date February 22, 2024
Actual Study Start Date  ICMJE July 19, 2022
Estimated Primary Completion Date May 19, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2021)
  • 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
  • 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
  • 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
  • Adverse Events [ Time Frame: Week 0 to Week 12 ]
    Number of adverse events reported in erenumab group compared to placebo
  • Return to Full Duty [ Time Frame: Week 0 to Week 12 ]
    Time to return to full activity as measured by the daily headache diary
  • Concomitant Medications [ Time Frame: Week 0 to Week 12 ]
    Monthly use of medications for acute headache treatment
  • Headache Days [ Time Frame: Week 0 to Week 12 ]
    Monthly headache days after early acute versus late acute administration of erenumab compared to placebo
  • 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
  • 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
  • HIT-6 [ Time Frame: Week 0 to Week 12 ]
    Change from baseline in headache impact scores as measured by the Headache Impact Test
  • 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.
  • ISI [ Time Frame: Week 0 to Week 12 ]
    Change from baseline in insomnia scores as measured by the Insomnia Severity Index
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 9, 2021)
  • 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
  • ASC-12 [ Time Frame: Week 0 to Week 12 ]
    Change from baseline in frequency of allodynia symptoms as measured by the Allodynia Symptom Checklist
  • ANAM [ Time Frame: Week 0 to Week 12 ]
    Change from baseline in neuropsychological functions as assessed by the Automated Neuropsychological Assessment Metrics
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI
Official Title  ICMJE 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
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Posttraumatic Headache
  • Mild Traumatic Brain Injury
Intervention  ICMJE
  • Drug: Erenumab 140 Mg/mL Subcutaneous Solution
    Active erenumab delivered via subcutaneous injection.
    Other Name: Aimovig
  • Drug: Placebo
    Placebo delivered via subcutaneous injection.
Study Arms  ICMJE
  • Experimental: Active Drug
    Erenumab administered once monthly via two 70-mg subcutaneous injections at 3 time points over a 12-week period.
    Intervention: Drug: Erenumab 140 Mg/mL Subcutaneous Solution
  • Placebo Comparator: Placebo
    Placebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2021)
404
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 19, 2027
Estimated Primary Completion Date May 19, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amy Guthrie, RN 202-924-2729 amy.guthrie.ctr@usuhs.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05049057
Other Study ID Numbers  ICMJE CNRM-CGRP-2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Current Responsible Party Henry M. Jackson Foundation for the Advancement of Military Medicine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Henry M. Jackson Foundation for the Advancement of Military Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David L Brody, MD, PhD Uniformed Services University of the Health Sciences
PRS Account Henry M. Jackson Foundation for the Advancement of Military Medicine
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP