A Phase 2 interventional study of Erenumab 140 Mg/mL Subcutaneous Solution and Placebo in Posttraumatic Headache and Mild Traumatic Brain Injury, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine · Phase 2, Interventional, and Treatment
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).
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.
192 studies on the registry are indexed under Post-Traumatic Headache; 54 are open to participants now.
This study's planned enrollment of 404 is above the median of 44 across 169 interventional studies indexed under Post-Traumatic Headache.
Browse Post-Traumatic Headache studies →Henry M. Jackson Foundation for the Advancement of Military Medicine is the lead sponsor of 86 studies on the registry; 18 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Placebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period.
Drug: Placebo
Drug page: Erenumab
Active erenumab delivered via subcutaneous injection.
Also known as: Aimovig
Placebo delivered via subcutaneous injection.
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Time frame: Week 8 to Week 12
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Time frame: Week 0 to Week 12
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Time frame: Week 0 to Week 4
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Time frame: Week 0 to Week 8
Adverse Events
Number of adverse events reported in erenumab group compared to placebo
Time frame: Week 0 to Week 12
Return to Full Duty
Time to return to full activity as measured by the daily headache diary
Time frame: Week 0 to Week 12
Concomitant Medications
Monthly use of medications for acute headache treatment
Time frame: Week 0 to Week 12
Headache Days
Monthly headache days after early acute versus late acute administration of erenumab compared to placebo
Time frame: Week 0 to Week 12
HPFID Activity
Monthly impact on everyday activity scores as measured by the Headache Physical Function Impact Diary Domain 1
Time frame: Week 0 to Week 12
HPFID Physical Impairment
Monthly impact on physical impairment scores as measured by the Headache Physical Function Impact Diary Domain 2
Time frame: Week 0 to Week 12
HIT-6
Change from baseline in headache impact scores as measured by the Headache Impact Test
Time frame: Week 0 to Week 12
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.
Time frame: Week 0 to Week 12
ISI
Change from baseline in insomnia scores as measured by the Insomnia Severity Index
Time frame: Week 0 to Week 12
MSQ
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
ASC-12
Change from baseline in frequency of allodynia symptoms as measured by the Allodynia Symptom Checklist
Time frame: Week 0 to Week 12
ANAM
Change from baseline in neuropsychological functions as assessed by the Automated Neuropsychological Assessment Metrics
Time frame: Week 0 to Week 12
Function of Time
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
Plan to share: Yes — 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.
Data sharing details ↗ · fitbir.nih.gov
No publications or documents are linked to this record.
Started Jul 2022 (actual). Primary completion is estimated for May 2026, 46 months after the start.
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Studies of the drug tested here: Erenumab
Henry M. Jackson Foundation for the Advancement of Military Medicine