Trigeminal neuralgia (TN) is one of the most painful and common types of neuropathic pain
encountered by clinicians. It is typically treated pharmacologically with anticonvulsants,but
these can be ineffective, or can lose their effectiveness over time.Botulinum toxin type A
(BoNT-A) is an exotoxin released by the Gram-positive, anaerobic bacillus Clostridium
botulinum that causes flaccid paralysis by blocking neurotransmitter release by axonal
terminals. As a contaminant, it is the cause of potentially lethal botulism poisoning;
however, as a drug, it has been widely used in the treatment of dystonia, as well as for
non-surgical cosmetic treatment. More recently, studies investigating the ability of BoNT-A
to treat pain have been increasing. In 2012, the investigators reported the results of a
randomized, double-blind, and placebo-controlled trial in which subcutaneous injection of
BoNT-A at the site of pain provided long-term effective relief in TN. The investigators noted
that adverse effects were mild, as well. Other studies on TN have estimated the effectiveness
of BoNT-A treatment in TN to be 47-73%. However, BoNT-A treatment is still ineffective in
more than 30% of patients.In this study, the investigators investigate whether different
treatment methods have different efficacy and safety.
Phase:
Phase 3
Details
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A onabotulinumtoxinA