Trigeminal NeuralgiaPhase 2NCT06410859

Botulinum Toxin Type A for Injection (HengLi®) in the Treatment of Trigeminal Neuralgia

A Phase 2 study testing Botulinum Toxin Type A for Injection,also known as "HengLi®" in people with Trigeminal Neuralgia, run by LKGS_277 at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To evaluate the efficacy of different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of trigeminal neuralgia (TN), so as to determine the optimal dosing regimen of the best administration scheme of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Trigeminal Neuralgia
What is being tested?: Botulinum Toxin Type A for Injection,also known as "HengLi®"
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 1 siteChina
Study dates: 25 Apr 2024to 30 Jun 2026
Phase: Phase 2
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Understand and voluntarily sign the written ICF;
Male or female 18 to 75 years of age (inclusive), able to provide legal identification;
Subjects clinically diagnosed as classical or idiopathic TN, with pain in one or two divisions (diagnostic criteria in the International Classification of Headache Disorders, 3rd Edition [ICHD-3], see Appendix 6);
Have a mean daily VAS score of ≥ 40 mm for 7 consecutive days during the screening period, with mean number of daily episodes ≥ 2, and duration of pain ≥ 3 months at screening;
Have a clear consciousness, the ability to perceive and resolve pain, the ability to understand and cooperate with the clinical study process, and the ability to comply with the requirements of the study protocol until completion of the study;
Prior first-line drug therapy (carbamazepine, oxcarbazepine) for TN;
Women of childbearing potential (WOCBP) should have a negative pregnancy test within 7 days prior to the first dose, and subjects and their partners should have no pregnancy plan and promise to use a medically acceptable contraceptive measure (e.g., intrauterine device [IUD], contraceptive pill or condom) during the study drug treatment period and within 3 months after the last dose of study drug; Note: WOCBP is defined as non-postmenopausal women who have experienced menarche and have not undergone sterilization (hysterectomy or bilateral adnexectomy) or other causes of permanent infertility (e.g., mullerian agenesis) identified by investigator. Postmenopause is defined as amenorrhea for ≥12 months without other biological or physiological causes.

Who cannot join

Subjects with TN who have a history of surgical treatment, such as percutaneous radiofrequency thermocoagulation of trigeminal ganglion, Meckel's cave compression, stereotactic gamma knife radiotherapy. and microvascular decompression;
Change in the dose and type of drugs for treatment of TN changed within 4 weeks prior to the first dose (including carbamazepine, oxcarbazepine, gabapentin, lamotrigine, etc.);
Subjects who have received injection therapy (magnesium sulfate injection), physical therapy, or traditional Chinese medicine treatment of TN within 4 weeks prior to the first dose, such as ultrashort wave, magnetic therapy, acupuncture, traditional Chinese medicines, etc.;
Patients who have received any botulinum agent within 6 months prior to the first dose;
Patients with secondary TN confirmed by magnetic resonance imaging (MRI);
Patients with systemic neuromuscular junction disorders, such as myasthenia, Eaton Lambert syndrome, amyotrophic (spinal cord) lateral sclerosis, multiple sclerosis, etc.;

Show all 14Show fewer

Subjects who have used drugs affecting neuromuscular junction within 7 days prior to the first dose (for example, aminoglycoside antibiotics [e.g., gentamycin, etc.], quinine, and penicillamine) or need to use the above drugs, cholinesterase antagonists, succinylcholine, curare-like depolarizing antagonists, magnesium sulfate, quinidine, calcium channel blockers (excluding antihypertensive agents such as amlodipine besylate and nifedipine), lincomycin, polymyxin, etc. during the conduct of the clinical trial;
There are conditions that investigator believes may affect pain assessment, such as skin disorders in the affected skin areas and may affect sensation, or the recommended injection sites have localized infection or are locally accompanied by other skin disorders;
Concurrent or prior hemorrhagic conditions, or intake of anticoagulants [e.g. heparin, coumarins, non-vitamin K antagonists, oral anticoagulants (e.g., apixaban, dabigatran, edoxaban, rivaroxaban), but aspirin and other platelet aggregation inhibitors such as ticlopidine, clopidogrel, prasugrel, abciximab, eptifibatide, and tirofiban are allowed] within 10 days prior to injection;
Chronic systemic diseases, which may affect subject's participation in the study as assessed by investigator, including but not limited to:
1）、Severe cardiopulmonary diseases, such as unstable angina pectoris, myocardial infarction, and severe arrhythmia, World Health Organization (WHO) cardiac function classification of Class III to IV at screening, hypertension poorly controlled with active treatment, systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at the time of screening; recurrent asthmatic attacks, etc.; 2）、Cerebrovascular accident (e.g., cerebral infarction, transient ischemic attack, etc.) within 6 months prior to screening; 3）、History of malignant tumor (excluding cured skin basal cell carcinoma, carcinoma in situ, and papillary thyroid carcinoma) or history of anti-tumor treatment within 5 years prior to screening; 4）、Other severe or unstable medical conditions (such as systemic infection, lung diseases, liver, cardiovascular, kidney or gastrointestinal diseases, etc.) assessed by investigator; 11、Severe hematological, liver, and renal dysfunction, with any one of the following clinical laboratory test results:
、Hematology: neutrophil count (ANC) < 1.5 × 109/L, or platelet count < 90 × 109/L, or hemoglobin < 100 g/L;
、Hepatic function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN); or total bilirubin (TBIL)> 1.5 × ULN;
、Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (calculated according to the simplified MDRD formula); 12、Presence of nervous/mental system disorders, which, in the investigator's opinion, may affect the evaluation of TN or self-scoring, including psychiatric disorders such as epilepsy, recurrent dizziness, headache, memory and cognitive impairment, severe depression, and schizophrenia, or other nervous system disorders except TN, such as headache and migraine; 13、Pregnant women and subjects in pregnancy or lactation; 14、Patients with known hypersensitivity to botulinum toxin type A and any ingredient in the formulation (sucrose, dextran, and gelatin) or with an allergic constitution; 15、Use of prohibited medications (see Section 6.5. 2) prior to screening. If a subject has used any prohibited medication before screening, screening is not allowed unless medication have been discontinued for at least 5 half-lives (see the labeling for the specific half-life) before the signing of ICF, and the medication is prohibited throughout the study; 16、Known history of drug/alcohol abuse; 17、Hepatitis B virus deoxyribonucleic acid (HBV-DNA) higher than the upper limit of detection, hepatitis C virus antibody (HCV-Ab) and HCV ribonucleic acid (RNA) positive, human immunodeficiency virus antibody (HIV Ab) positive, and serum Treponema pallidum antibody (TPPA method) positive at screening, or any of them; 18、Corneal ulcer; 19、Other conditions that make use of botulinum therapy unsuitable or may damage the safety of subjects or may make it impossible to complete the study in compliance with the protocol, as assessed by investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Randomized, Double-blind, Parallel, Placebo-controlled, Multicenter, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety, and Immunogenicity of Botulinum Toxin Type A for Injection (HengLi®) in the Treatment of Trigeminal Neuralgia

Read the detailed description

This study plans to enroll 240 subjects, and the efficacy measures [VAS score, DSIS score, daily pain duration (if applicable), and number of daily pain episodes] will be collected from subjects using the electronic Patient-Reported Outcomes (ePRO) throughout the study. The study period mainly consists of a screening period (14 days before the first dose), a double-blind treatment period (from the first dose to Week 12), and an extension period (from Week 13 to Week 52), including a maximum of 4 treatment cycles (each cycle lasts 12 week)

Conditions: Trigeminal Neuralgia
Being tested: Botulinum Toxin Type A for Injection,also known as "HengLi®"
Keywords: Botulinum Toxin Type A for Injection (HengLi®)
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 for Injection,also known as "HengLi®"Drug
This study plans to enroll 240 subjects, and the efficacy measures [VAS score, DSIS score, daily pain duration (if applicable), and number of daily pain episodes] will be collected from subjects using the electronic Patient-Reported Outcomes (ePRO) throughout the study. The study period mainly consists of a screening period (14 days before the first dose), a double-blind treatment period (from the first dose to Week 12), and an extension period (from Week 13 to Week 52), including a maximum of 4 treatment cycles (each cycle lasts 12 week)

Study groups in NCT06410859
Study group	Role	What they receive
Botulinum Toxin Type A for Injection(5U/site）	Experimental	5U/site Receives: Drug: Botulinum Toxin Type A for Injection,also known as "HengLi®"
Botulinum Toxin Type A for Injection（2.5U/site）	Experimental	2.5U/site Receives: Drug: Botulinum Toxin Type A for Injection,also known as "HengLi®"
placebo	Experimental	0U/site Receives: Drug: Botulinum Toxin Type A for Injection,also known as "HengLi®"

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the efficacy of different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of trigeminal neuralgia (TN), so as to determine the optimal dosing regimen of the best administration scheme of BoNTA
Change in mean visual analogue scale (VAS) score at Week 12 from the mean VAS score over one week at baseline.
for VAS,Pain was scored on a scale of 0 to10, with 0 indicating no pain, 10 indicating severe pain, and the middle part indicating varying degrees of pain.
Measured: Week 12

Secondary outcomes (10)

To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN.
Changes in the mean visual analogue scale (VAS) scores of Week 4 and 8 of the double-blind treatment period from the mean VAS score over one week at baseline;
Measured: week4,week 8
To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN.
Changes in the mean number of daily pain episodes at Week 4, 8, and 12 of the double-blind treatment period from the mean number of daily pain episodes over one week at baseline;
Measured: week4,week 8,week 12
To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN.
Changes in mean daily pain duration of subjects with persistent pain over one week [only those with persistent pain (such as dull pain) judged by investigator] at Week 4, 8, and 12 of the double-blind treatment period from the mean daily pain duration over one week at baseline;
Measured: week4,week8,week 12
To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN.
Effect of the investigational product versus placebo on Patient Global Impression of Change (PGIC, Appendix 2) at Week 4 and 12 of the double-blind treatment period;PGIC is a 7-point scale reporting the patient's overall improvement in pain status:(1)very much improved;(2)much improved;(3)minimally improved;(4)no change;(5) minimally worse;(6)much worse;(7)very much worse
Measured: week4,week 12
To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN.
Proportions of subjects with ≥ 50% and ≥ 30% reductions in mean visual analogue scale (VAS) score at Week 4, 8, and 12 of the double-blind treatment period from the mean VAS score over one week at baseline;for VAS,Pain was scored on a scale of 0 to10, with 0 indicating no pain, 10 indicating severe pain, and the middle part indicating varying degrees of pain.
Measured: week4,week8,week 12
To evaluate the efficacy of Botulinum Toxin Type A for Injection (HengLi®) following multiple doses.
Change in mean visual analogue scale (VAS) score of one week from the mean VAS score over one-week at baseline in subjects under continued observation for duration of response to a single dose in the extension period, every 4 week from Week 16 (i.e., Week 16, 20, 24, and so on) until no response (improvement in VAS score from baseline < 50%) or completion of the study.for VAS,Pain was scored on a scale of 0 to10, with 0 indicating no pain, 10 indicating severe pain, and the middle part indicating varying degrees of pain.
Measured: from date of randomization until the date of no response(improvement in VAS score from baseline < 50% )or date of study completion,whichever came first,assessed up to 52 weeks
To evaluate the efficacy of Botulinum Toxin Type A for Injection (HengLi®) following multiple doses.
Change in visual analogue scale (VAS) score of one week from the mean VAS score over one-week at baseline in subjects receiving additional doses in the extension period, every 4 week after each dose (i.e., 4 week, 8 week, 12 week, and so on) until the next dose or completion of the study;for VAS,Pain was scored on a scale of 0 to10, with 0 indicating no pain, 10 indicating severe pain, and the middle part indicating varying degrees of pain.
Measured: from date of randomization until the date of next dose or date of study completion,whichever came first,assessed up to 52 weeks
To evaluate the efficacy of Botulinum Toxin Type A for Injection (HengLi®) following multiple doses.
Change in mean number of daily pain episodes of one week from the mean number of daily pain episodes over one week at baseline in subjects under continued observation for duration of response to a single dose in the extension period, every 4 weeks from Week 16 (i.e., Week 16, 20, 24, and so on) until no response (improvement in visual analogue scale (VAS) score from baseline < 50%) or completion of the study;
Measured: from date of randomization until the date of no response(improvement in VAS score from baseline < 50% )or date of study completion,whichever came first,assessed up to 52 weeks
To evaluate the efficacy of Botulinum Toxin Type A for Injection (HengLi®) following multiple doses.
Change in mean number of daily pain episodes of one week from the mean number of daily pain episodes over one week at baseline in subjects receiving additional doses in the extension period, every 4 week after each dose (i.e., 4 week, 8 week, 12 week, and so on) until the next dose or completion of the study;
Measured: from date of randomization until the date of next dose or date of study completion,whichever came first,assessed up to 52 weeks
To evaluate the efficacy of Botulinum Toxin Type A for Injection (HengLi®) following multiple doses.
Change in mean daily pain duration of subjects with persistent pain over one week [only those with persistent pain (such as dull pain) judged by investigator] from the mean daily pain duration over one week at baseline among subjects under continued observation for duration of response to a single dose in the extension period, every 4 week from Week 16 (i.e., Week 16, 20, 24, and so on) until no response (improvement in visual analogue scale (VAS)score from baseline < 50%) or completion of the study;
Measured: from date of randomization until the date of no response(improvement in VAS score from baseline < 50% )or date of study completion,whichever came first,assessed up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 202430 Jun 2026

First posted13 May 2024
Study start25 Apr 2024
Primary completion30 Jun 2026 (estimated)
Study completion30 Jun 2026 (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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 240 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06410859
Sponsor's protocol ID: HengLi009-Ⅱ
Status last verified: May 2024
First submitted: 14 Apr 2024
Last updated: 13 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Trigeminal Neuralgia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Parallel, Placebo-controlled, Multicenter, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety, and Immunogenicity of Botulinum Toxin Type A for Injection (HengLi®) in the Treatment of Trigeminal Neuralgia
ClinicalTrials.gov ID: NCT06410859
Acronym / sponsor ID: HengLi009-Ⅱ
Conditions: Trigeminal Neuralgia
Keywords: Botulinum Toxin Type A for Injection (HengLi®)
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 240 participants (estimated)
Lead sponsor: LKGS_277Industry (pharma, biotech, devices)
Study start: 25 Apr 2024 (actual)
Primary completion: 30 Jun 2026 (estimated)
Study completion: 30 Jun 2026 (estimated)
First posted: 13 May 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Botulinum Toxin Type A for Injection(5U/site）	Experimental	Drug: Botulinum Toxin Type A for Injection,also known as "HengLi®"5U/site
Botulinum Toxin Type A for Injection（2.5U/site）	Experimental	Drug: Botulinum Toxin Type A for Injection,also known as "HengLi®"2.5U/site
placebo	Experimental	Drug: Botulinum Toxin Type A for Injection,also known as "HengLi®"0U/site

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Understand and voluntarily sign the written ICF;
Male or female 18 to 75 years of age (inclusive), able to provide legal identification;
Subjects clinically diagnosed as classical or idiopathic TN, with pain in one or two divisions (diagnostic criteria in the International Classification of Headache Disorders, 3rd Edition [ICHD-3], see Appendix 6);
Have a mean daily VAS score of ≥ 40 mm for 7 consecutive days during the screening period, with mean number of daily episodes ≥ 2, and duration of pain ≥ 3 months at screening;
Have a clear consciousness, the ability to perceive and resolve pain, the ability to understand and cooperate with the clinical study process, and the ability to comply with the requirements of the study protocol until completion of the study;

Key exclusion criteria (14 listed)

Subjects with TN who have a history of surgical treatment, such as percutaneous radiofrequency thermocoagulation of trigeminal ganglion, Meckel's cave compression, stereotactic gamma knife radiotherapy. and microvascular decompression;
Change in the dose and type of drugs for treatment of TN changed within 4 weeks prior to the first dose (including carbamazepine, oxcarbazepine, gabapentin, lamotrigine, etc.);
Subjects who have received injection therapy (magnesium sulfate injection), physical therapy, or traditional Chinese medicine treatment of TN within 4 weeks prior to the first dose, such as ultrashort wave, magnetic therapy, acupuncture, traditional Chinese medicines, etc.;
Patients who have received any botulinum agent within 6 months prior to the first dose;
Patients with secondary TN confirmed by magnetic resonance imaging (MRI);

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 for Injection,also known as "HengLi®"This study plans to enroll 240 subjects, and the efficacy measures [VAS score, DSIS score, daily pain duration (if applicable), and number of daily pain episodes] will be collected from subjects using the electronic Patient-Reported Outcomes (ePRO) throughout the study. The study period mainly consists of a screening period (14 days before the first dose), a double-blind treatment period (from the first dose to Week 12), and an extension period (from Week 13 to Week 52), including a maximum of 4 treatment cycles (each cycle lasts 12 week)	Drug	Botulinum Toxin Type A for Injection(5U/site）, Botulinum Toxin Type A for Injection（2.5U/site）, placebo

Primary outcome

To evaluate the efficacy of different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of trigeminal neuralgia (TN), so as to determine the optimal dosing regimen of the best administration scheme of BoNTA
Time frame: Week 12
Change in mean visual analogue scale (VAS) score at Week 12 from the mean VAS score over one week at baseline. for VAS,Pain was scored on a scale of 0 to10, with 0 indicating no pain, 10 indicating severe pain, and the middle part indicating varying degrees of pain.

10 secondary outcomes

To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN.
Time frame: week4,week 8
To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN.
Time frame: week4,week 8,week 12
To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN.
Time frame: week4,week8,week 12
To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN.
Time frame: week4,week 12
To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN.
Time frame: week4,week8,week 12
To evaluate the efficacy of Botulinum Toxin Type A for Injection (HengLi®) following multiple doses.
Time frame: from date of randomization until the date of no response(improvement in VAS score from baseline < 50% )or date of study completion,whichever came first,assessed up to 52 weeks
To evaluate the efficacy of Botulinum Toxin Type A for Injection (HengLi®) following multiple doses.
Time frame: from date of randomization until the date of next dose or date of study completion,whichever came first,assessed up to 52 weeks
To evaluate the efficacy of Botulinum Toxin Type A for Injection (HengLi®) following multiple doses.
Time frame: from date of randomization until the date of no response(improvement in VAS score from baseline < 50% )or date of study completion,whichever came first,assessed up to 52 weeks
To evaluate the efficacy of Botulinum Toxin Type A for Injection (HengLi®) following multiple doses.
Time frame: from date of randomization until the date of next dose or date of study completion,whichever came first,assessed up to 52 weeks
To evaluate the efficacy of Botulinum Toxin Type A for Injection (HengLi®) following multiple doses.
Time frame: from date of randomization until the date of no response(improvement in VAS score from baseline < 50% )or date of study completion,whichever came first,assessed up to 52 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.

Related trials for Trigeminal Neuralgia

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Botulinum Toxin Type A for Injection,also known as "HengLi®" in people with Trigeminal Neuralgia, run by LKGS_277 at 1 site 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 7 inclusion and 14 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 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the efficacy of different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of trigeminal neuralgia (TN), so as to determine the optimal dosing regimen of the best administration scheme of BoNTA (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06410859.

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 13 May 2024.