Abobotulinumtoxina Efficacy in Post-Traumatic Headache

• Status: Completed
• Trial end date: 2017-02-02
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VA Greater Los Angeles Healthcare System
• Collaborator: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

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.