Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

Phase 3

Terminated

• Conditions: Chronic Post Traumatic Headache
• Interventions: Drug: OnabotulinumtoxinA

• Registration Number: NCT02160535
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-10
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Results First Submitted: 2017-10-25
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-20
• Last Update Submitted: 2018-10-20
• Results First Posted: 2018-10-23
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with OnabotulinumtoxinA	OnabotulinumtoxinA	OnabotulinumtoxinA

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University of Washington Headache Clinic; 🇺🇸 Seattle, Washington, United States