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Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

Primary Purpose

Chronic Post Traumatic Headache

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
OnabotulinumtoxinA
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Post Traumatic Headache focused on measuring Mild Traumatic Brain Injury, Concussion, Post Concussive Headache

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Washington Headache Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with OnabotulinumtoxinA

Arm Description

OnabotulinumtoxinA

Outcomes

Primary Outcome Measures

Change in Mean Percentage of Headache Days
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

Change in SF-36 Assessment Scores
Short Form-36 (SF-36) assesses quality of life. Minimum score: 0 Maximum score: 100 Higher values show improvement in quality of life.
Change in MIDAS Score
Migraine Disability Assessment Minimum score: 0 Maximum score: 270 Lower values show improvement in disability.
Change in HIT-6 Score.
Headache Impact Test-6 Minimum value: 36 Maximum value: 78 Lower values represent less disability.

Full Information

First Posted
May 15, 2014
Last Updated
October 20, 2018
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT02160535
Brief Title
Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
Official Title
Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Study discontinued due to difficulty in enrolling eligible subjects
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Post Traumatic Headache
Keywords
Mild Traumatic Brain Injury, Concussion, Post Concussive Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with OnabotulinumtoxinA
Arm Type
Experimental
Arm Description
OnabotulinumtoxinA
Intervention Type
Drug
Intervention Name(s)
OnabotulinumtoxinA
Other Intervention Name(s)
BOTOX
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Mean Percentage of Headache Days
Description
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).
Time Frame
Baseline, 9 months
Secondary Outcome Measure Information:
Title
Change in SF-36 Assessment Scores
Description
Short Form-36 (SF-36) assesses quality of life. Minimum score: 0 Maximum score: 100 Higher values show improvement in quality of life.
Time Frame
Baseline and 9 month.
Title
Change in MIDAS Score
Description
Migraine Disability Assessment Minimum score: 0 Maximum score: 270 Lower values show improvement in disability.
Time Frame
Baseline and 9 month.
Title
Change in HIT-6 Score.
Description
Headache Impact Test-6 Minimum value: 36 Maximum value: 78 Lower values represent less disability.
Time Frame
Baseline and 9 month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvia Lucas, MD, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Headache Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

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