Clinical trial NCT03928496: Abobotulinumtoxina Efficacy in Post-Traumatic Headache
Official title: Abobotulinumtoxina Efficacy in Post-Traumatic Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Traumatic Headache
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
Collaborators: name: Ipsen
First posted: 2019-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of abobotulinumtoxina on Veterans with post-traumatic headache

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Incidence of headaches from baseline
timeFrame: evaluation from time of injection until completion of 12 week follow-up
Secondary outcomes:
measure: Intensity of headache pain
timeFrame: evaluation from time of injection until completion of 12 week follow-up
measure: Number of headache days per week
timeFrame: evaluation from time of injection until completion of 12 week follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
Study officials:
affiliation: VA Greater Los Angeles
name: Milena Zirovich, MD
role: PRINCIPAL_INVESTIGATOR
References: