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Botulinum Toxin for Trigeminal Neuralgia (EASTERN)

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ClinicalTrials.gov Identifier: NCT03331913
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Chuanjie Wu, The First Affiliated Hospital of Zhengzhou University

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.

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Drug: Botulinum Toxin type A (intradermal / submucosal injection at pain area) Drug: Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Botulinum Toxin for the Treatment of Trigeminal Neuralgia: Comparison of Two Different Treatment Methods
Actual Study Start Date : November 7, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: intradermal / submucosal injection group
intradermal / submucosal injection at pain area
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

Experimental: intra-masseter injection group
intra-masseter injection on the ipsilateral of pain involved
Drug: 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




Primary Outcome Measures :
  1. Pain relief [ Time Frame: 4 weeks ]
    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


Secondary Outcome Measures :
  1. Visual Analogue Scale score [ Time Frame: 1 week ]
    Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache

  2. Visual Analogue Scale score [ Time Frame: 2 weeks ]
    Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache

  3. Visual Analogue Scale score [ Time Frame: 3 weeks ]
    Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache

  4. Visual Analogue Scale score [ Time Frame: 4 weeks ]
    Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache

  5. Visual Analogue Scale score [ Time Frame: 5 weeks ]
    Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache

  6. Visual Analogue Scale score [ Time Frame: 6 weeks ]
    Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache

  7. Visual Analogue Scale score [ Time Frame: 7 weeks ]
    Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache

  8. Visual Analogue Scale score [ Time Frame: 8 weeks ]
    Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache

  9. Visual Analogue Scale score [ Time Frame: 9 weeks ]
    Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache

  10. Visual Analogue Scale score [ Time Frame: 10 weeks ]
    Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache

  11. Visual Analogue Scale score [ Time Frame: 11 weeks ]
    Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache

  12. Visual Analogue Scale score [ Time Frame: 12 weeks ]
    Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache

  13. The overall response to treatment on the Patient Global Impression of Change [ Time Frame: 8 weeks ]

Other Outcome Measures:
  1. Safety which is assessed by adverse reactions [ Time Frame: 12 weeks ]
    Adverse reactions



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331913


Contacts
Contact: Chuanjie Wu, MD 008615903676787 wuchuanjie8557@163.com
Contact: Yajun Lian, MD 008613838367143 lianyajun369@yahoo.com

Locations
China, Beijing
Xuanwu Hospital Captial Medical University Recruiting
Beijing, Beijing, China
Contact: Xunming Ji, MD         
China, Guizhou
Guizhou Provincial People's Hospital Recruiting
Guiyang, Guizhou, China
Contact: Lu Wang, MD         
China, Henan
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450000
Contact: Yajun Lian, MD    008613838367143    lianyajun369@yahoo.com   
China, Hunan
Xiangtan Central Hospital Recruiting
Xiangtan, Hunan, China
Contact: Yong Liang, MD         
China, Sichuan
Luzhou People's Hospital Recruiting
Luzhou, Sichuan, China
Contact: Li Zhou, MD         
Sponsors and Collaborators
The First Affiliated Hospital of Zhengzhou University
Investigators
Study Chair: Chuanjie Wu, MD Xuanwu Hospital Captial Medical University

Responsible Party: Chuanjie Wu, MD, PhD, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT03331913     History of Changes
Other Study ID Numbers: FAHZU-2017-025
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neuralgia
Trigeminal Neuralgia
Trigeminal Nerve Diseases
Facial Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents