Clinical trial NCT02160535: Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
Official title: Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Post Traumatic Headache
Keywords: Mild Traumatic Brain Injury
Concussion
Post Concussive Headache
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Mean Percentage of Headache Days
timeFrame: Baseline, 9 months
Secondary outcomes:
measure: Change in SF-36 Assessment Scores
timeFrame: Baseline and 9 month.
measure: Change in MIDAS Score
timeFrame: Baseline and 9 month.
measure: Change in HIT-6 Score.
timeFrame: Baseline and 9 month.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Headache Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Sylvia Lucas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: