Trigeminal NeuralgiaPhase 3EASTERNNCT03331913
Botulinum Toxin for Trigeminal Neuralgia
A Phase 3 study testing 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 people with Trigeminal Neuralgia, run by The First Affiliated Hospital of Zhengzhou University at 5 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Botulinum Toxin type A (intradermal / submucosal injection at pain area) and Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesChina
- Study dates
- 7 Nov 2017to 31 Mar 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Xuanwu Hospital Captial Medical University
Beijing, Beijing Municipality
Xunming Ji, MD
- Recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou
Lu Wang, MD
- Recruiting
Luzhou People's Hospital
Luzhou, Sichuan
Li Zhou, MD
- Recruiting
Xiangtan Central Hospital
Xiangtan, Hunan
Yong Liang, MD
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Yajun Lian, MD, 008613838367143, lianyajun369@yahoo.com
About this study
Official title: The Efficacy and Safety of Botulinum Toxin for the Treatment of Trigeminal Neuralgia: Comparison of Two Different Treatment Methods
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.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Botulinum Toxin type A (intradermal / submucosal injection at pain area), Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved)
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin type A (intradermal / submucosal injection at pain area)Drug
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)Drug
Comparison of two different treatment methods of Botulinum Toxin type A for the treatment of trigeminal neuralgia
| Study group | Role | What they receive |
|---|---|---|
| intradermal / submucosal injection group | Active comparator | intradermal / submucosal injection at pain area Receives: Drug: Botulinum Toxin type A (intradermal / submucosal injection at pain area) |
| intra-masseter injection group | Experimental | intra-masseter injection on the ipsilateral of pain involved Receives: Drug: Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (13)
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Measured: 1 week
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Measured: 2 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Measured: 3 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Measured: 4 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Measured: 5 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Measured: 6 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Measured: 7 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Measured: 8 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Measured: 9 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Measured: 10 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Measured: 11 weeks
Visual Analogue Scale score
Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
Measured: 12 weeks
The overall response to treatment on the Patient Global Impression of Change
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start7 Nov 2017
- Primary completion28 Feb 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuanjie Wu, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Chuanjie Wu, MD, Study chair, Xuanwu Hospital Captial Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331913
- Sponsor's protocol ID
- FAHZU-2017-025
- Acronym
- EASTERN
- Status last verified
- Nov 2018
- First submitted
- 30 Oct 2017
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Botulinum Toxin for the Treatment of Trigeminal Neuralgia: Comparison of Two Different Treatment Methods
- ClinicalTrials.gov ID
- NCT03331913
- Acronym / sponsor ID
- EASTERN / FAHZU-2017-025
- Conditions
- Trigeminal Neuralgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intradermal / submucosal injection group | Active comparator | Drug: Botulinum Toxin type A (intradermal / submucosal injection at pain area)intradermal / submucosal injection at pain area |
| intra-masseter injection group | Experimental | Drug: Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved)intra-masseter injection on the ipsilateral of pain involved |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | intradermal / submucosal injection group |
| 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 | Drug | intra-masseter injection group |
Primary outcome
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
13 secondary outcomes
Visual Analogue Scale score
Time frame: 1 week
Visual Analogue Scale score
Time frame: 2 weeks
Visual Analogue Scale score
Time frame: 3 weeks
Visual Analogue Scale score
Time frame: 4 weeks
Visual Analogue Scale score
Time frame: 5 weeks
Visual Analogue Scale score
Time frame: 6 weeks
Visual Analogue Scale score
Time frame: 7 weeks
Visual Analogue Scale score
Time frame: 8 weeks
Visual Analogue Scale score
Time frame: 9 weeks
Visual Analogue Scale score
Time frame: 10 weeks
Visual Analogue Scale score
Time frame: 11 weeks
Visual Analogue Scale score
Time frame: 12 weeks
The overall response to treatment on the Patient Global Impression of Change
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuanjie Wu, MD study chair
Xuanwu Hospital Captial Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 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 people with Trigeminal Neuralgia, run by The First Affiliated Hospital of Zhengzhou University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuanjie Wu, MD (008615903676787, wuchuanjie8557@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.