NCT03331913: EASTERN

Botulinum Toxin for Trigeminal Neuralgia

Status unknown Phase 3 Last updated 26 November 2018

What this trial tests

Phase 3 trial testing Botulinum Toxin type A (intradermal / submucosal injection at pain area) in Trigeminal Neuralgia in 150 participants. Status unknown.

Timeline

7 November 2017

Primary endpoint
28 February 2019

31 March 2019

Quick facts

Lead sponsor	The First Affiliated Hospital of Zhengzhou University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	150
Start date	7 November 2017
Primary completion	28 February 2019
Estimated completion	31 March 2019
Sites	5 locations across China

Drugs / interventions tested

• Botulinum Toxin type A (intradermal / submucosal injection at pain area) — full drug profile →
• Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved) — full drug profile →

Conditions studied

• Trigeminal Neuralgia — all drugs for Trigeminal Neuralgia →

Sponsor

The First Affiliated Hospital of Zhengzhou University

Who can join

18 and older, any sex, with Trigeminal Neuralgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Current and Innovative Pharmacological Options to Treat Typical and Atypical Trigeminal Neuralgia.
   Di Stefano G, Truini A, Cruccu G. · · 2018 · cited 64× · PMID 30178160 · DOI 10.1007/s40265-018-0964-9