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

Primary Purpose

Posttraumatic Headache, Mild Traumatic Brain Injury

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erenumab 140 Mg/mL Subcutaneous Solution
Placebo
Sponsored by
Henry M. Jackson Foundation for the Advancement of Military Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Headache

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Womack Army Medical Center - Fort BraggRecruiting
  • Naval Medical Center Camp LejeuneRecruiting
  • Brooke Army Medical Center - Fort Sam HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Drug

Placebo

Arm Description

Erenumab administered once monthly via two 70-mg subcutaneous injections at 3 time points over a 12-week period.

Placebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period.

Outcomes

Primary Outcome Measures

Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary

Secondary Outcome Measures

Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Adverse Events
Number of adverse events reported in erenumab group compared to placebo
Return to Full Duty
Time to return to full activity as measured by the daily headache diary
Concomitant Medications
Monthly use of medications for acute headache treatment
Headache Days
Monthly headache days after early acute versus late acute administration of erenumab compared to placebo
HPFID Activity
Monthly impact on everyday activity scores as measured by the Headache Physical Function Impact Diary Domain 1
HPFID Physical Impairment
Monthly impact on physical impairment scores as measured by the Headache Physical Function Impact Diary Domain 2
HIT-6
Change from baseline in headache impact scores as measured by the Headache Impact Test
PHQ-9
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
Change from baseline in insomnia scores as measured by the Insomnia Severity Index

Full Information

First Posted
July 26, 2021
Last Updated
September 28, 2022
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05049057
Brief Title
Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2022 (Actual)
Primary Completion Date
May 19, 2026 (Anticipated)
Study Completion Date
May 19, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Headache, Mild Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
404 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Drug
Arm Type
Experimental
Arm Description
Erenumab administered once monthly via two 70-mg subcutaneous injections at 3 time points over a 12-week period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period.
Intervention Type
Drug
Intervention Name(s)
Erenumab 140 Mg/mL Subcutaneous Solution
Other Intervention Name(s)
Aimovig
Intervention Description
Active erenumab delivered via subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo delivered via subcutaneous injection.
Primary Outcome Measure Information:
Title
Monthly Headache Days
Description
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Time Frame
Week 8 to Week 12
Secondary Outcome Measure Information:
Title
Monthly Headache Days
Description
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Time Frame
Week 0 to Week 12
Title
Monthly Headache Days
Description
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Time Frame
Week 0 to Week 4
Title
Monthly Headache Days
Description
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Time Frame
Week 0 to Week 8
Title
Adverse Events
Description
Number of adverse events reported in erenumab group compared to placebo
Time Frame
Week 0 to Week 12
Title
Return to Full Duty
Description
Time to return to full activity as measured by the daily headache diary
Time Frame
Week 0 to Week 12
Title
Concomitant Medications
Description
Monthly use of medications for acute headache treatment
Time Frame
Week 0 to Week 12
Title
Headache Days
Description
Monthly headache days after early acute versus late acute administration of erenumab compared to placebo
Time Frame
Week 0 to Week 12
Title
HPFID Activity
Description
Monthly impact on everyday activity scores as measured by the Headache Physical Function Impact Diary Domain 1
Time Frame
Week 0 to Week 12
Title
HPFID Physical Impairment
Description
Monthly impact on physical impairment scores as measured by the Headache Physical Function Impact Diary Domain 2
Time Frame
Week 0 to Week 12
Title
HIT-6
Description
Change from baseline in headache impact scores as measured by the Headache Impact Test
Time Frame
Week 0 to Week 12
Title
PHQ-9
Description
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.
Time Frame
Week 0 to Week 12
Title
ISI
Description
Change from baseline in insomnia scores as measured by the Insomnia Severity Index
Time Frame
Week 0 to Week 12
Other Pre-specified Outcome Measures:
Title
MSQ
Description
Change from baseline in quality of life scores as measured by the Migraine-specific Quality of Life Questionnaire
Time Frame
Week 0 to Week 12
Title
ASC-12
Description
Change from baseline in frequency of allodynia symptoms as measured by the Allodynia Symptom Checklist
Time Frame
Week 0 to Week 12
Title
ANAM
Description
Change from baseline in neuropsychological functions as assessed by the Automated Neuropsychological Assessment Metrics
Time Frame
Week 0 to Week 12
Title
Function of Time
Description
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
Time Frame
0-24 hours, 24-72 hours, 72-144 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annabel Lee Raboy
Phone
301-461-1067
Email
annabellee.raboy.ctr@usuhs.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Molly Malarkey
Email
molly.malarkey.ctr@usuhs.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L Brody, MD, PhD
Organizational Affiliation
Uniformed Services University of the Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Womack Army Medical Center - Fort Bragg
City
Fort Bragg
State/Province
North Carolina
ZIP/Postal Code
28310
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Calley Smith
Phone
240-653-6725
Email
calley.c.smith.ctr@mail.mil
First Name & Middle Initial & Last Name & Degree
CAPT Scott Klimp
Facility Name
Naval Medical Center Camp Lejeune
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28547
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Hill
Phone
910-450-3768
Email
heather.hill.ctr@usuhs.edu
First Name & Middle Initial & Last Name & Degree
CAPT Diana Fu
Facility Name
Brooke Army Medical Center - Fort Sam Houston
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Guthrie
Phone
210-275-8108
Email
amy.e.guthrie.ctr@mail.mil
First Name & Middle Initial & Last Name & Degree
Maj Tyler Davis

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
http://fitbir.nih.gov/content/access-data

Learn more about this trial

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

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