Chronic Post Traumatic Headache
Conditions
Keywords
Mild Traumatic Brain Injury, Concussion, Post Concussive Headache
Brief summary
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
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.
Interventions
DRUGOnabotulinumtoxinA
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
Sponsors
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Percentage of Headache Days | Baseline, 9 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SF-36 Assessment Scores | Baseline and 9 month. | Short Form-36 (SF-36) assesses quality of life. Minimum score: 0 Maximum score: 100 Higher values show improvement in quality of life. |
| Change in MIDAS Score | Baseline and 9 month. | Migraine Disability Assessment Minimum score: 0 Maximum score: 270 Lower values show improvement in disability. |
| Change in HIT-6 Score. | Baseline and 9 month. | Headache Impact Test-6 Minimum value: 36 Maximum value: 78 Lower values represent less disability. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment With OnabotulinumtoxinA OnabotulinumtoxinA
OnabotulinumtoxinA: 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 | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Treatment With OnabotulinumtoxinA | — |
|---|---|---|
| Age, Categorical <=18 years | 1 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 12 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 13 participants | — |
| Sex: Female, Male Female | 12 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
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).
Time frame: Baseline, 9 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment With OnabotulinumtoxinA | Change in Mean Percentage of Headache Days | Baseline | 83 percentage of headache days | Standard Deviation 21 |
| Treatment With OnabotulinumtoxinA | Change in Mean Percentage of Headache Days | 9 month | 49 percentage of headache days | Standard Deviation 34 |
Secondary
Change in HIT-6 Score.
Headache Impact Test-6 Minimum value: 36 Maximum value: 78 Lower values represent less disability.
Time frame: Baseline and 9 month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment With OnabotulinumtoxinA | Change in HIT-6 Score. | Baseline | 65 score on a scale | Standard Deviation 4 |
| Treatment With OnabotulinumtoxinA | Change in HIT-6 Score. | 9 months | 59 score on a scale | Standard Deviation 7 |
Secondary
Change in MIDAS Score
Migraine Disability Assessment Minimum score: 0 Maximum score: 270 Lower values show improvement in disability.
Time frame: Baseline and 9 month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment With OnabotulinumtoxinA | Change in MIDAS Score | Baseline | 89 score on a scale | Standard Deviation 51 |
| Treatment With OnabotulinumtoxinA | Change in MIDAS Score | 9 months | 21 score on a scale | Standard Deviation 18 |
Secondary
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.
Time frame: Baseline and 9 month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment With OnabotulinumtoxinA | Change in SF-36 Assessment Scores | Baseline | 47 score on a scale | Standard Deviation 30 |
| Treatment With OnabotulinumtoxinA | Change in SF-36 Assessment Scores | 9 months | 66 score on a scale | Standard Deviation 29 |