Abobotulinumtoxina Efficacy in Post-Traumatic Headache

Post-Traumatic Headache Clinical Trial

Official title:

Abobotulinumtoxina Efficacy in Post-Traumatic Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03928496
• Other study ID #: Zirovich0002
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2013
• Est. completion date: February 2, 2017

Study information

• Verified date: April 2019
• Source: VA Greater Los Angeles Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2, 2017
• Est. primary completion date: February 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Traumatic Headache

Intervention

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

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Greater Los Angeles Healthcare System	Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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