Abobotulinumtoxina Efficacy in Post-Traumatic Headache

V

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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