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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
Sponsor:
Information provided by (Responsible Party):
Sylvia Lucas, University of Washington

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Post Traumatic Headache
Intervention Drug: OnabotulinumtoxinA
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment With OnabotulinumtoxinA
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OnabotulinumtoxinA

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

Period Title: Overall Study
Started 13
Completed 10
Not Completed 3
Arm/Group Title Treatment With OnabotulinumtoxinA
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OnabotulinumtoxinA

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

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
1
   7.7%
Between 18 and 65 years
12
  92.3%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
12
  92.3%
Male
1
   7.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Change in Mean Percentage of Headache Days
Hide Description 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).
Time Frame Baseline, 9 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment With OnabotulinumtoxinA
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OnabotulinumtoxinA

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

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: percentage of headache days
Baseline 83  (21)
9 month 49  (34)
2.Secondary Outcome
Title Change in SF-36 Assessment Scores
Hide Description Short Form-36 (SF-36) assesses quality of life. Minimum score: 0 Maximum score: 100 Higher values show improvement in quality of life.
Time Frame Baseline and 9 month.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment With OnabotulinumtoxinA
Hide Arm/Group Description:

OnabotulinumtoxinA

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

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 47  (30)
9 months 66  (29)
3.Secondary Outcome
Title Change in MIDAS Score
Hide Description Migraine Disability Assessment Minimum score: 0 Maximum score: 270 Lower values show improvement in disability.
Time Frame Baseline and 9 month.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment With OnabotulinumtoxinA
Hide Arm/Group Description:

OnabotulinumtoxinA

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

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 89  (51)
9 months 21  (18)
4.Secondary Outcome
Title Change in HIT-6 Score.
Hide Description Headache Impact Test-6 Minimum value: 36 Maximum value: 78 Lower values represent less disability.
Time Frame Baseline and 9 month.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment With OnabotulinumtoxinA
Hide Arm/Group Description:

OnabotulinumtoxinA

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

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 65  (4)
9 months 59  (7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment With OnabotulinumtoxinA
Hide Arm/Group Description

OnabotulinumtoxinA

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

All-Cause Mortality
Treatment With OnabotulinumtoxinA
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment With OnabotulinumtoxinA
Affected / at Risk (%) # Events
Total   0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment With OnabotulinumtoxinA
Affected / at Risk (%) # Events
Total   1/13 (7.69%)    
General disorders   
Increased Headache  [1]  1/13 (7.69%)  1
Indicates events were collected by systematic assessment
[1]
One subject experienced increased headache after treatment. Event thought to be local effect from injection sites and subject's sensitization to repetitive needle sticks.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Sylvia Lucas, MD, PhD
Organization: University of Washington
Phone: 206-598-9260
EMail: lucass@uw.edu
Responsible Party: Sylvia Lucas, University of Washington
ClinicalTrials.gov Identifier: NCT02160535     History of Changes
Other Study ID Numbers: 46614
First Submitted: May 15, 2014
First Posted: June 10, 2014
Results First Submitted: October 25, 2017
Results First Posted: October 23, 2018
Last Update Posted: October 23, 2018