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Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02160535
Recruitment Status : Terminated (Study discontinued due to difficulty in enrolling eligible subjects)
First Posted : June 10, 2014
Results First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):
Sylvia Lucas, University of Washington

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.

Condition or disease Intervention/treatment Phase
Chronic Post Traumatic Headache Drug: OnabotulinumtoxinA Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
Study Start Date : May 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Headache

Arm Intervention/treatment
Experimental: Treatment with 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 Name: BOTOX

Primary Outcome Measures :
  1. Change in Mean Percentage of Headache Days [ Time Frame: Baseline, 9 months ]
    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 :
  1. Change in SF-36 Assessment Scores [ Time Frame: Baseline and 9 month. ]
    Short Form-36 (SF-36) assesses quality of life. Minimum score: 0 Maximum score: 100 Higher values show improvement in quality of life.

  2. Change in MIDAS Score [ Time Frame: Baseline and 9 month. ]
    Migraine Disability Assessment Minimum score: 0 Maximum score: 270 Lower values show improvement in disability.

  3. Change in HIT-6 Score. [ Time Frame: Baseline and 9 month. ]
    Headache Impact Test-6 Minimum value: 36 Maximum value: 78 Lower values represent less disability.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02160535

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United States, Washington
University of Washington Headache Clinic
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
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Principal Investigator: Sylvia Lucas, MD, PhD University of Washington
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Responsible Party: Sylvia Lucas, Clinical Professor, University of Washington Identifier: NCT02160535    
Other Study ID Numbers: 46614
First Posted: June 10, 2014    Key Record Dates
Results First Posted: October 23, 2018
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sylvia Lucas, University of Washington:
Mild Traumatic Brain Injury
Post Concussive Headache
Additional relevant MeSH terms:
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Post-Traumatic Headache
Tension-Type Headache
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Headache Disorders, Primary
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents