Abobotulinumtoxina Efficacy in Post-Traumatic Headache

Study Overview
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Brief Summary
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This study will evaluate the efficacy of abobotulinumtoxina on Veterans with post-traumatic headache

Detailed Description
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A significant proportion of headaches occur following head trauma, and therefore are referred to as post-traumatic headaches (PTH). Traumatic brain injury (TBI) is highly prevalent in the Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) population and consequently there has been a rise in PTH in the clinical setting at VA hospitals. Botulinum toxin type A (BoNT-A) has been shown to be effective in treating chronic migraine and chronic daily headache. It is therefore reasonable to predict that BoNT-A may also be effective in treating PTH. This study proposes that PTH and its associated symptoms may respond positively to BoNT-A treatment due to its similar pathophysiology and clinical resemblance to other headache disorders including tension type headache, typical migraine with or without aura, and chronic daily headache. Study Design: Veterans with mild, moderate or severe brain injury with a headache developing within 7 days after head trauma and persisting greater than 3 months were recruited from the Veterans Affairs Greater Los Angeles Healthcare System. The study is a prospective, double-blind, randomized, placebo-controlled, cross-over trial.

Official Title
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Abobotulinumtoxina Efficacy in Post-Traumatic Headache

Conditions
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Post-Traumatic Headache

Intervention / Treatment
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* Drug: AbobotulinumtoxinA
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female age 18-65 meets International Classification Headache Disorders II (ICHD-II) criteria for post-traumatic headache average pain score of greater than 4/10 in severity on the numerical rating system Rancho Los Amigos cognitive scale score greater than seven. Exclusion Criteria: Uncontrolled medical condition other than PTH Severe additional chronic pain complaint which could not be distinguished from headache pain pregnancy, breast feeding, prior treatment with botulinum toxin within one year of enrollment current substance abuse/dependence medical condition that would increase risk of neuromuscular junction blockade with botulinum toxin (myasthenia gravis, Eaton Lambert, amyotrophic lateral sclerosis) poorly controlled psychiatric initiation of a new anti-depressant or anti-seizure medication within three months of enrolling in study ongoing disability or litigation claim.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abobotulinumtoxina<br>300 units of abobotulinumtoxinA was reconstituted with 2.4 ml of 0.9% preservative free sterile saline so that each 0.1 ml contained 12.5 units of Abobotulinumtoxina 0.1 ml were injected into 31 sites of the head and neck | Drug: AbobotulinumtoxinA<br>* Subjects were injected with 0.1 ml (12.5 units of Abobotulinumtoxina) into 31 distinct muscle locations in the head and neck<br>* Other names: Dysport;|
| Placebo Comparator: Placebo<br>0.9% preservative free sterile saline. 0.1 ml were injected into 31 sites of the head and neck | Drug: Normal saline<br>* Subjects were injected with 0.1 ml of preservative free normal saline into 31 distinct muscle locations in the head and neck<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of headaches from baseline | Evaluation in weekly incidence of headaches from baseline based on headache diary or weekly phone follow-up | evaluation from time of injection until completion of 12 week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of headache pain | Evaluation of pain intensity using score of headache on Numerical Rating Scale (NRS) over time. The NRS is an 11-point scale for patient self-reporting of pain with 0 being no pain and 10 being the most severe pain. | evaluation from time of injection until completion of 12 week follow-up | 
| Number of headache days per week | Evaluation of the number of days a headache was present over each week | evaluation from time of injection until completion of 12 week follow-up |