Abobotulinumtoxina Efficacy in Post-Traumatic Headache
Keywords
Abstract
Description
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.
Dates
| Last Verified: | 03/31/2019 |
| First Submitted: | 04/17/2019 |
| Estimated Enrollment Submitted: | 04/23/2019 |
| First Posted: | 04/25/2019 |
| Last Update Submitted: | 04/23/2019 |
| Last Update Posted: | 04/25/2019 |
| Actual Study Start Date: | 07/31/2013 |
| Estimated Primary Completion Date: | 02/01/2017 |
| Estimated Study Completion Date: | 02/01/2017 |
Condition or disease
Intervention/treatment
Drug: Abobotulinumtoxina
Drug: Placebo
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Abobotulinumtoxina 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 Subjects were injected with 0.1 ml (12.5 units of Abobotulinumtoxina) into 31 distinct muscle locations in the head and neck |
| Placebo Comparator: Placebo 0.9% preservative free sterile saline. 0.1 ml were injected into 31 sites of the head and neck | Drug: Placebo Subjects were injected with 0.1 ml of preservative free normal saline into 31 distinct muscle locations in the head and neck |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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. |
Outcome
Primary Outcome Measures
1. Incidence of headaches from baseline [evaluation from time of injection until completion of 12 week follow-up]
Secondary Outcome Measures
1. Intensity of headache pain [evaluation from time of injection until completion of 12 week follow-up]
2. Number of headache days per week [evaluation from time of injection until completion of 12 week follow-up]
