A Phase 3 interventional study of Botulinum Toxin type A (intradermal / submucosal injection at pain area) and Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved) in Trigeminal Neuralgia, sponsored by The First Affiliated Hospital of Zhengzhou University. Status unknown at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-26.
Sponsored by The First Affiliated Hospital of Zhengzhou University · Phase 3, Interventional, and Treatment
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Among 17 studies in Trigeminal Neuralgia with a site in China — 6 open to participants now, 6 under way, none of them phase 3. Trigeminal Neuralgia · China.
Among the 17 studies in Trigeminal Neuralgia with a site in China, this one is the 4th largest by planned enrollment of the 13 interventional ones that give a count, is one of 3 that started in 2017, is the only one in phase 3, and was the 6th registered.
140 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.
Browse Trigeminal Neuralgia studies →6 of the 17 studies in Trigeminal Neuralgia with a site in China are open now. Recruiting first, the newest first:
Beijing Tiantan Hospital · Sites in China
Ages 18+
Beijing Tiantan Hospital · Sites in China
Ages 18–75
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Sites in China
Ages 18+
Meiqing Wang · Sites in China
Ages 18+
LKGS_277 · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 27 Trigeminal Neuralgia studies recruiting now, 18 (67%) set no upper age limit and 3 (11%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 1 · Phase 4 2
First in 2008; this study’s year is marked. 3 started in 2017.
This study's planned enrollment of 150 is above the median of 40 across 93 interventional studies indexed under Trigeminal Neuralgia.
Median enrollment 134 across the 13 interventional studies, 83 across the 4 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
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2 of 17 have an industry lead sponsor. The 10 most frequent:
The First Affiliated Hospital of Zhengzhou University is the lead sponsor of 127 studies on the registry; 74 are open to participants now.
The First Affiliated Hospital of Zhengzhou University has 1 study filed under Trigeminal Neuralgia — fewer than ten, so there is no comparison to draw.
1 of the studies in Trigeminal Neuralgia with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07750730Beijing Hospital of Traditional Chinese MedicineClinical Efficacy and Peripheral Ultrasound Mechanism of Trigger Point Bloodletting Therapy for Primary Trigeminal Neuralgia | 2027-07-31 |
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Among the 17 studies in Trigeminal Neuralgia with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
intradermal / submucosal injection at pain area
Drug: Botulinum Toxin type A (intradermal / submucosal injection at pain area)
intra-masseter injection on the ipsilateral of pain involved
Drug: Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved)
Drug page: Botulinum toxin type A
Comparison of two different treatment methods of Botulinum Toxin type A for the treatment of trigeminal neuralgia
Comparison of two different treatment methods of Botulinum Toxin type A for the treatment of trigeminal neuralgia
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
Time frame: 4 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Time frame: 1 week
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Time frame: 2 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Time frame: 3 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Time frame: 4 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Time frame: 5 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Time frame: 6 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Time frame: 7 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Time frame: 8 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Time frame: 9 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Time frame: 10 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Time frame: 11 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Time frame: 12 weeks
The overall response to treatment on the Patient Global Impression of Change
Time frame: 8 weeks
Safety which is assessed by adverse reactions
Adverse reactions
Time frame: 12 weeks
Started Nov 2017 (actual). Primary completion is estimated for Feb 2019, 15 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A
The First Affiliated Hospital of Zhengzhou University →