Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

Study Overview
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Brief Summary
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This study will provide evidence on whether the use of an FDA-approved drug therapy for the treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the head, or a fall, or a motor vehicle accident, or some other traumatic event.

Detailed Description
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Headaches caused by trauma are called post-traumatic headaches (PTH). The Center for Disease Control estimates that between 1.4 and 1.8 million civilians in the US sustain a traumatic brain injury (TBI) each year. The objectives of the study will be evaluated in a civilian population which has sustained a mild Traumatic Brain Injury (mTBI). Research has found that the total cost due to headache in the US workforce is $20 billion per year, most of which is in the form of reduce productivity while at work. For patients with TBI who are already struggling with cognitive and health challenges in an effort to be productive, it seems reasonable to suspect that chronic PTH may slow rehabilitation efforts and successful re-entry into the work force and societal responsibility. Results from this study have the potential to contribute to recommendations for treatment of chronic PTH.

Official Title
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Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

Conditions
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Chronic Post Traumatic Headache

Intervention / Treatment
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* Drug: OnabotulinumtoxinA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of mild traumatic brain injury (mTBI) within the past 15 months Suffer at least fifteen total headache days per month Ability to speak and read English Exclusion Criteria: Subject with hypersensitivity reactions or other intolerance to OnabotulinumtoxinA Previous use of OnabotulinumtoxinA for treatment of headache Any medications commonly used as headache preventives started less than 3 months prior to enrollment Prior or current diagnosis of major psychiatric disorder or other central nervous system disorder Less than 80% compliance (recorded for less than 24 days) in the 30 day screening headache diary Subjects who are pregnant or trying to become pregnant within the timeframe of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with OnabotulinumtoxinA<br>OnabotulinumtoxinA | Drug: OnabotulinumtoxinA<br>* 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache<br>* Other names: BOTOX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Percentage of Headache Days | To measure average number of headache days three months after the last onaboltulinumtoxinA injection and compare to average number of headache days during screening month (and present as percentage of headache change). | Baseline, 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SF-36 Assessment Scores | Short Form-36 (SF-36) assesses quality of life. Minimum score: 0 Maximum score: 100 Higher values show improvement in quality of life. | Baseline and 9 month. | 
| Change in MIDAS Score | Migraine Disability Assessment Minimum score: 0 Maximum score: 270 Lower values show improvement in disability. | Baseline and 9 month. | 
| Change in HIT-6 Score. | Headache Impact Test-6 Minimum value: 36 Maximum value: 78 Lower values represent less disability. | Baseline and 9 month. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Traumatic Brain Injury, Concussion, Post Concussive Headache