NCT03331913

Botulinum Toxin for Trigeminal Neuralgia

The Efficacy and Safety of Botulinum Toxin for the Treatment of Trigeminal Neuralgia: Comparison of Two Different Treatment Methods

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
DRUG	Botulinum Toxin type A (intradermal / submucosal injection at pain area)	Comparison of two different treatment methods of Botulinum Toxin type A for the treatment of trigeminal neuralgia
DRUG	Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved)	Comparison of two different treatment methods of Botulinum Toxin type A for the treatment of trigeminal neuralgia

Timeline

• Start date: 2017-11-07
• Primary completion: 2019-02-28
• Completion: 2019-03-31
• First posted: 2017-11-06
• Last updated: 2018-11-26

Locations

5 sites across 1 country: China