Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Post Traumatic Headache
• Intervention / Treatment: Drug: OnabotulinumtoxinA

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Headache Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with OnabotulinumtoxinA; OnabotulinumtoxinA	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; Other Names: BOTOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 9 month.
Change in MIDAS Score	Migraine Disability Assessment Minimum score: 0 Maximum score: 270 Lower values show improvement in disability.	Baseline and 9 month.
Change in HIT-6 Score.	Headache Impact Test-6 Minimum value: 36 Maximum value: 78 Lower values represent less disability.	Baseline and 9 month.

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Sylvia Lucas, MD, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: May 15, 2014
• First Submitted That Met QC Criteria: June 6, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 20, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Concussion; Mild Traumatic Brain Injury; Post Concussive Headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache Disorders, Secondary; Headache; Tension-Type Headache; Post-Traumatic Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 46614

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No