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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

Tracking Information
First Submitted Date  ICMJE May 15, 2014
First Posted Date  ICMJE June 10, 2014
Results First Submitted Date  ICMJE October 25, 2017
Results First Posted Date  ICMJE October 23, 2018
Last Update Posted Date October 23, 2018
Study Start Date  ICMJE May 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
To determine whether OnabotulinumtoxinA is an effective treatment for chronic post-traumatic headache (PTH) following mild traumatic brain injury (mTBI). [ Time Frame: Baseline, 3 months, 6 months, and 9 months after treatment ]
Subjects complete headache diary entries every day while enrolled in the study. The primary outcome measure is a statistically significant reduction in the number of headaches recorded at screening versus the intervals every three months after treatment and at the final visit.
Change History Complete list of historical versions of study NCT02160535 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
To assess whether treatment results in improvement of quality of life and a reduction of disability in individuals suffering from chronic PTH. [ Time Frame: Subjects complete assessments at five timepoints: Screening, Injection visit 1, Injection visit 2(90 days after previous visit), Injection visit 3(90 days after previous visit), and the Final visit(90 days after previous visit). ]
Assessments include the following: Short Form 36 (SF-36) Short Form 12 (SF-12) Headache Impact Test-6 (HIT-6) Migraine Disability Assessment Test (MIDAS) Assessments will be administered to all subjects. Results will be evaluated to measure improvement from the first assessment at screening versus the four interval assessment done during the study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
Official Title  ICMJE Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Post Traumatic Headache
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Treatment with OnabotulinumtoxinA
Intervention: Drug: OnabotulinumtoxinA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 27, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2014)
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02160535
Other Study ID Numbers  ICMJE 46614
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sylvia Lucas, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sylvia Lucas, MD, PhD University of Washington
PRS Account University of Washington
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP