Abobotulinumtoxina Efficacy in Post-Traumatic Headache

VA Greater Los Angeles Healthcare System

Status and phase: Completed; Phase 4

Conditions: Post-Traumatic Headache

Treatments: Drug: Normal saline; Drug: AbobotulinumtoxinA

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT03928496

Zirovich0002

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Abobotulinumtoxina

Experimental group

Description:

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

Treatment:

Drug: AbobotulinumtoxinA

Placebo

Placebo Comparator group

Description:

0.9% preservative free sterile saline. 0.1 ml were injected into 31 sites of the head and neck

Treatment:

Drug: Normal saline