Botulinum Toxin for Trigeminal Neuralgia (EASTERN)

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

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.

Study Overview

• Status: Unknown
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Drug: Botulinum Toxin type A (intradermal / submucosal injection at pain area); Drug: Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved)

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chuanjie Wu, MD; Phone Number: 008615903676787; Email: wuchuanjie8557@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Xuanwu Hospital Captial Medical University
      • Contact: Xunming Ji, MD
  • Guizhou
    • Guiyang, Guizhou, China
      • Recruiting
      • Guizhou Provincial People's Hospital
      • Contact: Lu Wang, MD
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • The First Affiliated hospital of Zhengzhou University
  • Hunan
    • Xiangtan, Hunan, China
      • Recruiting
      • Xiangtan Central Hospital
      • Contact: Yong Liang, MD
  • Sichuan
    • Luzhou, Sichuan, China
      • Recruiting
      • Luzhou People's Hospital
      • Contact: Li Zhou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >18 years
• Clinical diagnosis of classical trigeminal neuralgia according to the ICHD III (beta)
• The pain involved the gingiva
• Signed informed consent prior to entering study

Exclusion Criteria:

• comorbid diseases that may be exacerbated by botulinum toxin type A (e.g., myasthenia gravis, motor neuron disease, or Lambert-Eaton syndrome).
• receiving drugs with neuromuscular junction toxicity 1 week before botulinum toxin type A treatment (e.g. quinine, aminoglycosides or penicillamine)
• had an infection of the skin or mucosa at any of the injection sites.
• psychiatric illness.
• malignancy.
• pregnancy or lactation.
• currently participating or previously participated in any investigational drug or device study within 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intradermal / submucosal injection group; intradermal / submucosal injection at pain area	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
Experimental: intra-masseter injection group; intra-masseter injection on the ipsilateral of pain involved	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief	Pain relief was defined as ≥50% reduction in Visual Analogue Scale score which is an 11 point scale from 0 - 10 with 0 being no headache	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	1 week
Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	2 weeks
Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	3 weeks
Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	4 weeks
Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	5 weeks
Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	6 weeks
Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	7 weeks
Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	8 weeks
Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	9 weeks
Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	10 weeks
Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	11 weeks
Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	12 weeks
The overall response to treatment on the Patient Global Impression of Change		8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety which is assessed by adverse reactions	Adverse reactions	12 weeks

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhengzhou University
• Investigators: Study Chair: Chuanjie Wu, MD, Xuanwu Hospital Captial Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2017
• Primary Completion (Anticipated): February 28, 2019
• Study Completion (Anticipated): March 31, 2019

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 1, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 22, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: FAHZU-2017-025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No