NCT02160535

Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Post Traumatic Headache

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-06-10
• Last updated: 2018-10-23
• Results posted: 2018-10-23

Locations

1 site across 1 country: United States