Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

Stopped early · Phase 3

Conditions studied: Chronic Post Traumatic Headache

In brief

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.

Key facts

Study ID

NCT02160535

Run by

University of Washington

People needed

13

Starts

2014-05-01

Expected to finish

2016-08-01

Last updated by the study team

2018-10-23

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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