Mild Traumatic Brain Injury, Posttraumatic Headache
Conditions
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.
Interventions
DRUGErenumab 140 Mg/mL Subcutaneous Solution
Active erenumab delivered via subcutaneous injection.
DRUGPlacebo
Placebo delivered via subcutaneous injection.
Sponsors
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monthly Headache Days | Week 8 to Week 12 | Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ISI | Week 0 to Week 12 | Change from baseline in insomnia scores as measured by the Insomnia Severity Index |
| HPFID Activity | 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 | Week 0 to Week 12 | Monthly impact on physical impairment scores as measured by the Headache Physical Function Impact Diary Domain 2 |
| HIT-6 | Week 0 to Week 12 | Change from baseline in headache impact scores as measured by the Headache Impact Test |
| PHQ-9 | 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. |
| Monthly Headache Days | Week 0 to Week 12 | Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary |
| Adverse Events | Week 0 to Week 12 | Number of adverse events reported in erenumab group compared to placebo |
| Return to Full Duty | Week 0 to Week 12 | Time to return to full activity as measured by the daily headache diary |
| Concomitant Medications | Week 0 to Week 12 | Monthly use of medications for acute headache treatment |
| Headache Days | Week 0 to Week 12 | Monthly headache days after early acute versus late acute administration of erenumab compared to placebo |
Other
| Measure | Time frame | Description |
|---|---|---|
| MSQ | 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 | Week 0 to Week 12 | Change from baseline in frequency of allodynia symptoms as measured by the Allodynia Symptom Checklist |
| ANAM | Week 0 to Week 12 | Change from baseline in neuropsychological functions as assessed by the Automated Neuropsychological Assessment Metrics |
| Function of Time | 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 |
Countries
United States
Contacts
Primary ContactAmy Guthrie, RN
Outcome results
None listed