Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Post Traumatic Headache||Drug: OnabotulinumtoxinA||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Treatment with 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
- 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).
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02160535
|United States, Washington|
|University of Washington Headache Clinic|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Sylvia Lucas, MD, PhD||University of Washington|