Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

NCT ID: NCT02160535

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-08-31

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.

Conditions

Chronic Post Traumatic Headache

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with OnabotulinumtoxinA

OnabotulinumtoxinA

Group Type: EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

BOTOX

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Sylvia Lucas

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sylvia Lucas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Headache Clinic

Seattle, Washington, United States

Countries

United States

Other Identifiers

46614

Identifier Type: -

Identifier Source: org_study_id