Clinical Trial: Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

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 Summary: 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.
Sponsor: University of Washington

Current Primary Outcome: To determine whether OnabotulinumtoxinA is an effective treatment for chronic post-traumatic headache (PTH) following mild traumatic brain injury (mTBI). [ Time Frame: Baseline, 3 months, 6 months, and 9 months after treatment ]

Subjects complete headache diary entries every day while enrolled in the study. The primary outcome measure is a statistically significant reduction in the number of headaches recorded at screening versus the intervals every three months after treatment and at the final visit.


Original Primary Outcome: Same as current

Current Secondary Outcome: To assess whether treatment results in improvement of quality of life and a reduction of disability in individuals suffering from chronic PTH. [ Time Frame: Subjects complete assessments at five timepoints: Screening, Injection visit 1, Injection visit 2(90 days after previous visit), Injection visit 3(90 days after previous visit), and the Final visit(90 days after previous visit). ]

Assessments include the following:

Short Form 36 (SF-36) Headache Impact Test-6 (HIT-6) Migraine Disability Assessment Test (MIDAS) Assessments will be administered to all subjects. Results will be evaluated to measure improvement from the first assessment at screening versus the four interval assessment done during the study.



Original Secondary Outcome: To assess whether treatment results in improvement of quality of life and a reduction of disability in individuals suffering from chronic PTH. [ Time Frame: Subjects complete assessments at five timepoints: Screening, Injection visit 1, Injection visit 2(90 days after previous visit), Injection visit 3(90 days after previous visit), and the Final visit(90 days after previous visit). ]

Assessments include the following:

Short Form 36 (SF-36) Short Form 12 (SF-12) Headache Impact Test-6 (HIT-6) Migraine Disability Assessment Test (MIDAS) Assessments will be administered to all subjects. Results will be evaluated to measure improvement from the first assessment at screening versus the four interval assessment done during the study.



Information By: University of Washington

Dates:
Date Received: May 15, 2014
Date Started: May 2014
Date Completion:
Last Updated: February 27, 2017
Last Verified: February 2017