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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Drug | Experimental | Erenumab administered once monthly via two 70-mg subcutaneous injections at 3 time points over a 12-week period. |
|
| Placebo | Placebo Comparator | Placebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erenumab 140 Mg/mL Subcutaneous Solution | Drug | Active erenumab delivered via subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monthly Headache Days | Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary | Week 8 to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Monthly Headache Days | Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary | Week 0 to Week 12 |
| Monthly Headache Days | Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary |
| Measure | Description | Time Frame |
|---|---|---|
| MSQ | Change from baseline in quality of life scores as measured by the Migraine-specific Quality of Life Questionnaire | Week 0 to Week 12 |
| ASC-12 | Change from baseline in frequency of allodynia symptoms as measured by the Allodynia Symptom Checklist |
Inclusion Criteria:
Exclusion Criteria:
Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury:
Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Guthrie, RN | Contact | 202-924-2729 | amy.guthrie.ctr@usuhs.edu |
| Name | Affiliation | Role |
|---|---|---|
| David L Brody, MD, PhD | Uniformed Services University of the Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Womack Army Medical Center - Fort Liberty | Recruiting | Fort Bragg | North Carolina | 28310 | United States |
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
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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 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.
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| Placebo | Drug | Placebo delivered via subcutaneous injection. |
|
| Week 0 to Week 4 |
| Monthly Headache Days | Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary | Week 0 to Week 8 |
| Adverse Events | Number of adverse events reported in erenumab group compared to placebo | Week 0 to Week 12 |
| Return to Full Duty | Time to return to full activity as measured by the daily headache diary | Week 0 to Week 12 |
| Concomitant Medications | Monthly use of medications for acute headache treatment | Week 0 to Week 12 |
| Headache Days | Monthly headache days after early acute versus late acute administration of erenumab compared to placebo | Week 0 to Week 12 |
| HPFID Activity | Monthly impact on everyday activity scores as measured by the Headache Physical Function Impact Diary Domain 1 | 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 | Week 0 to Week 12 |
| HIT-6 | Change from baseline in headache impact scores as measured by the Headache Impact Test | 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. | Week 0 to Week 12 |
| ISI | Change from baseline in insomnia scores as measured by the Insomnia Severity Index | Week 0 to Week 12 |
| Week 0 to Week 12 |
| ANAM | Change from baseline in neuropsychological functions as assessed by the Automated Neuropsychological Assessment Metrics | 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 | 0-24 hours, 24-72 hours, 72-144 hours |
| University of Pittsburgh Concussion Research Laboratory | Not yet recruiting | Pittsburgh | Pennsylvania | 15203 | United States |
|
| William Beaumont Army Medical Center | Recruiting | El Paso | Texas | 79918 | United States |
|
| Madigan Army Medical Center | Not yet recruiting | Tacoma | Washington | 98431 | United States |
|
| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
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| ID | Term |
|---|---|
| C000605816 | erenumab |
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