Trial · NCT02088632
Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia
NCT02088632, Phase 2, Terminated, Thomas Jefferson University; results first posted 2023-06-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia. Trials, record NCT02088632. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02088632
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia
- NCT number
- NCT02088632
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Thomas Jefferson University
- Conditions
- Trigeminal Neuralgia
- Interventions
- Incobotulinumtoxina, Placebo Comparator
- First posted
- 2014-03-17
- Last updated
- 2023-06-28
- Results first posted
- 2023-06-28
- Limitations and caveats
- Very slow enrollment and low number of participants limited study. Study was terminated prior to analysis. The data was highly skewed.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Number of Headache Attacks Reported in Active and Placebo Group | 84 days | Mean daily number of attacks during baseline period (30 days) will be compared to mean daily number of attacks for baseline and 84 days as recorded in patient diary. |
| Secondary | Change in Mean Pain Intensity of Active and Placebo Group | 84 days | Mean of the daily pain intensity as measured on a 0-10 pain scale where 0 = no pain and 10 is the worst pain reported on paper diary from baseline and 84 days |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Number of Headache Attacks Reported in Active and Placebo Group | 84 days | Patients treated with Xeomin and patients treated with placebo | attacks per day | MEAN |
| SECONDARY | Change in Mean Pain Intensity of Active and Placebo Group | 84 days | Descriptive statistics only | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Number of Headache Attacks Reported in Active and Placebo Group | Active | 1.96 | Standard Deviation 2.9 | attacks per day | |
| Change in Mean Number of Headache Attacks Reported in Active and Placebo Group | Placebo Group | -200.133 | Standard Deviation 286.9 | attacks per day | |
| Change in Mean Pain Intensity of Active and Placebo Group | Active | -2.66 | Standard Deviation .98 | units on a scale | |
| Change in Mean Pain Intensity of Active and Placebo Group | Placebo | .73 | Standard Deviation .54 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Incobotulinumtoxina | 3 | |
| Overall Study | STARTED | Placebo Comparator | 3 | |
| Overall Study | COMPLETED | Incobotulinumtoxina | 3 | |
| Overall Study | COMPLETED | Placebo Comparator | 3 | |
| Overall Study | NOT COMPLETED | Incobotulinumtoxina | 0 | |
| Overall Study | NOT COMPLETED | Placebo Comparator | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Drowsiness | General disorders | Incobotulinumtoxina | 1 | 3 | 1 |
| other | Drowsiness | General disorders | Placebo Comparator | 0 | 3 | 0 |
| other | muscle weakness | General disorders | Incobotulinumtoxina | 1 | 3 | 1 |
| other | muscle weakness | General disorders | Placebo Comparator | 0 | 3 | 0 |
| other | Aphthous ulcers | Skin and subcutaneous tissue disorders | Incobotulinumtoxina | 0 | 3 | 0 |
| other | Aphthous ulcers | Skin and subcutaneous tissue disorders | Placebo Comparator | 1 | 3 | 1 |
| other | Sinusitis | Infections and infestations | Incobotulinumtoxina | 1 | 3 | 1 |
| other | Sinusitis | Infections and infestations | Placebo Comparator | 0 | 3 | 0 |
| other | Numbness left temple | Nervous system disorders | Incobotulinumtoxina | 0 | 3 | 0 |
| other | Numbness left temple | Nervous system disorders | Placebo Comparator | 1 | 3 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Incobotulinumtoxina | 0 | 3 |
| Total, all-cause mortality | Placebo Comparator | 0 | 3 |
| Total, other adverse events | Incobotulinumtoxina | 2 | 3 |
| Total, other adverse events | Placebo Comparator | 3 | 3 |
| Total, serious adverse events | Incobotulinumtoxina | 0 | 3 |
| Total, serious adverse events | Placebo Comparator | 0 | 3 |
Source ClinicalTrials.gov
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Incobotulinumtoxina vs Placebo Comparator: deaths from any cause | Trial comparisons |
| Incobotulinumtoxina vs Placebo Comparator: serious adverse events | Trial comparisons |
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/NCT02088632
GET https://conductscience.org/api/trials/v1/NCT02088632/registered