Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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