Abobotulinumtoxina Efficacy in Post-Traumatic Headache

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

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Headache
• Intervention / Treatment: Drug: AbobotulinumtoxinA; Drug: Normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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; Other Names: Dysport
Placebo Comparator: Placebo; 0.9% preservative free sterile saline. 0.1 ml were injected into 31 sites of 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of headaches from baseline	Evaluation in weekly incidence of headaches from baseline based on headache diary or weekly phone follow-up	evaluation from time of injection until completion of 12 week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of headache pain	Evaluation of pain intensity using score of headache on Numerical Rating Scale (NRS) over time. The NRS is an 11-point scale for patient self-reporting of pain with 0 being no pain and 10 being the most severe pain.	evaluation from time of injection until completion of 12 week follow-up
Number of headache days per week	Evaluation of the number of days a headache was present over each week	evaluation from time of injection until completion of 12 week follow-up

Collaborators and Investigators

• Sponsor: VA Greater Los Angeles Healthcare System
• Collaborators: Ipsen
• Investigators: Principal Investigator: Milena Zirovich, MD, VA Greater Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): February 2, 2017
• Study Completion (Actual): February 2, 2017

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: Zirovich0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: A de-identified dataset may be provided upon request
• IPD Sharing Time Frame: Starting at 3 months following publication and up to 3 years after publication
• IPD Sharing Access Criteria: Data access requests will be reviewed and requestors will sign a data access agreement
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes