Botulinum Toxin for Trigeminal Neuralgia

NCT03331913 | Unknown Phase 3 DMC

• 1 other identifier: FAHZU-2017-025
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Visual Analogue Scale score

  1 week

• Visual Analogue Scale score

  2 weeks

• Visual Analogue Scale score

  3 weeks

• Visual Analogue Scale score

  4 weeks

• Visual Analogue Scale score

  5 weeks

Other Outcomes (1)

• Safety which is assessed by adverse reactions

  12 weeks

Study Arms (2)

intradermal / submucosal injection group

ACTIVE COMPARATOR

intradermal / submucosal injection at pain area

Drug: Botulinum Toxin type A (intradermal / submucosal injection at pain area)

intra-masseter injection group

EXPERIMENTAL

intra-masseter injection on the ipsilateral of pain involved

Drug: Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved)

Interventions

Botulinum Toxin type A (intradermal / submucosal injection at pain area) DRUG

Comparison of two different treatment methods of Botulinum Toxin type A for the treatment of trigeminal neuralgia

intradermal / submucosal injection group

Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved) DRUG

Comparison of two different treatment methods of Botulinum Toxin type A for the treatment of trigeminal neuralgia

intra-masseter injection group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (5)

Xuanwu Hospital Captial Medical University

Beijing, Beijing Municipality, China

RECRUITING

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

Xiangtan Central Hospital

Xiangtan, Hunan, China

RECRUITING

Luzhou People's Hospital

Luzhou, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Botulinum Toxins, Type A; Injections, Intradermal

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Chuanjie Wu, MD

  Xuanwu Hospital Captial Medical University

  STUDY CHAIR

Central Study Contacts

Chuanjie Wu, MD

CONTACT

008615903676787; wuchuanjie8557@163.com

Yajun Lian, MD

CONTACT

008613838367143; lianyajun369@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: November 7, 2017
• Primary Completion: February 28, 2019
• Study Completion: March 31, 2019
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

CN (5)