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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03331913
Other study ID # FAHZU-2017-025
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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