Status:
UNKNOWN
Botulinum Toxin for Trigeminal Neuralgia
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Conditions:
Trigeminal Neuralgia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ine...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2019
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03331913
Start Date
November 7 2017
End Date
March 31 2019
Last Update
November 26 2018
Active Locations (5)
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1
Xuanwu Hospital Captial Medical University
Beijing, Beijing Municipality, China
2
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
4
Xiangtan Central Hospital
Xiangtan, Hunan, China