NCT03928496

Abobotulinumtoxina Efficacy in Post-Traumatic Headache

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: VA Greater Los Angeles Healthcare System · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post-Traumatic Headache

Interventions

Type	Name	Description
DRUG	AbobotulinumtoxinA	Subjects were injected with 0.1 ml (12.5 units of Abobotulinumtoxina) into 31 distinct muscle locations in the head and neck
DRUG	Normal saline	Subjects were injected with 0.1 ml of preservative free normal saline into 31 distinct muscle locations in the head and neck

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-02-02
• Completion: 2017-02-02
• First posted: 2019-04-26
• Last updated: 2019-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study