Trial · NCT06410859
Botulinum Toxin Type A for Injection (HengLi®) in the Treatment of Trigeminal Neuralgia
NCT06410859, Phase 2, Unknown, LKGS_277
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Botulinum Toxin Type A for Injection (HengLi®) in the Treatment of Trigeminal Neuralgia. Trials, record NCT06410859. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06410859
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Botulinum Toxin Type A for Injection (HengLi®) in the Treatment of Trigeminal Neuralgia
- NCT number
- NCT06410859
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 240 participants, estimated
- Lead sponsor
- LKGS_277
- Conditions
- Trigeminal Neuralgia
- Interventions
- Botulinum Toxin Type A for Injection,also known as "HengLi®"
- First posted
- 2024-05-13
- Last updated
- 2024-05-13
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN. | week4,week 8 | 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; |
| Secondary | To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN. | week4,week 8,week 12 | 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; |
| Secondary | To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN. | week4,week8,week 12 | 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; |
| Secondary | To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN. | week4,week 12 | 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 |
| Secondary | To evaluate the duration of response to different dosing regimens of Botulinum Toxin Type A for Injection (HengLi®) in the treatment of TN. | week4,week8,week 12 | 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. |
| Secondary | To evaluate the efficacy of Botulinum Toxin Type A for Injection (HengLi®) following multiple doses. | 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 | 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. |
| Secondary | To evaluate the efficacy of Botulinum Toxin Type A for Injection (HengLi®) following multiple doses. | from date of randomization until the date of next dose or date of study completion,whichever came first,assessed up to 52 weeks | 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. |
| Secondary | To evaluate the efficacy of Botulinum Toxin Type A for Injection (HengLi®) following multiple doses. | 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 | 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; |
| Secondary | To evaluate the efficacy of Botulinum Toxin Type A for Injection (HengLi®) following multiple doses. | from date of randomization until the date of next dose or date of study completion,whichever came first,assessed up to 52 weeks | 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; |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06410859
GET https://conductscience.org/api/trials/v1/NCT06410859/registered