Clinical trial NCT03331913: Botulinum Toxin for Trigeminal Neuralgia
Official title: The Efficacy and Safety of Botulinum Toxin for the Treatment of Trigeminal Neuralgia: Comparison of Two Different Treatment Methods
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Trigeminal Neuralgia
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain relief
timeFrame: 4 weeks
Secondary outcomes:
measure: Visual Analogue Scale score
timeFrame: 1 week
measure: Visual Analogue Scale score
timeFrame: 2 weeks
measure: Visual Analogue Scale score
timeFrame: 3 weeks
measure: Visual Analogue Scale score
timeFrame: 4 weeks
measure: Visual Analogue Scale score
timeFrame: 5 weeks
measure: Visual Analogue Scale score
timeFrame: 6 weeks
measure: Visual Analogue Scale score
timeFrame: 7 weeks
measure: Visual Analogue Scale score
timeFrame: 8 weeks
measure: Visual Analogue Scale score
timeFrame: 9 weeks
measure: Visual Analogue Scale score
timeFrame: 10 weeks
measure: Visual Analogue Scale score
timeFrame: 11 weeks
measure: Visual Analogue Scale score
timeFrame: 12 weeks
measure: The overall response to treatment on the Patient Global Impression of Change
timeFrame: 8 weeks
Other outcomes:
measure: Safety which is assessed by adverse reactions
timeFrame: 12 weeks
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Captial Medical University
state: Beijing
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
city: Luzhou
country: China
facility: Luzhou People's Hospital
state: Sichuan
Study officials:
affiliation: Xuanwu Hospital Captial Medical University
name: Chuanjie Wu, MD
role: STUDY_CHAIR
References: