Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

University of Washington

Status and phase

Terminated

Phase 3

Conditions

Chronic Post Traumatic Headache

Treatments

Drug: OnabotulinumtoxinA

Study type

Interventional

Funder types

Other

Identifiers

NCT02160535

46614

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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