Botulinum Toxin for Trigeminal Neuralgia

Trigeminal Neuralgia Clinical Trial

— EASTERN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03331913
• Other study ID #: FAHZU-2017-025
• Status: Recruiting
• Phase: Phase 3
• Start date: November 7, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: November 2018
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Chuanjie Wu, MD
• Phone: 008615903676787
• Email: wuchuanjie8557[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

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
• 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

Locations

Country	Name	City	State
China	Xuanwu Hospital Captial Medical University	Beijing	Beijing
China	Guizhou Provincial People's Hospital	Guiyang	Guizhou
China	Luzhou People's Hospital	Luzhou	Sichuan
China	Xiangtan Central Hospital	Xiangtan	Hunan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety which is assessed by adverse reactions	Adverse reactions	12 weeks
Primary	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	Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	1 week
Secondary	Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	2 weeks
Secondary	Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	3 weeks
Secondary	Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	4 weeks
Secondary	Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	5 weeks
Secondary	Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	6 weeks
Secondary	Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	7 weeks
Secondary	Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	8 weeks
Secondary	Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	9 weeks
Secondary	Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	10 weeks
Secondary	Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	11 weeks
Secondary	Visual Analogue Scale score	Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache	12 weeks
Secondary	The overall response to treatment on the Patient Global Impression of Change		8 weeks