Trial · NCT07489430
DaxibotulinumtoxinA for Blepharospasm
NCT07489430, Phase 2, Recruiting, University of Pennsylvania
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DaxibotulinumtoxinA for Blepharospasm. Trials, record NCT07489430. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07489430
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DaxibotulinumtoxinA for Blepharospasm
- NCT number
- NCT07489430
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 20 participants, estimated
- Lead sponsor
- University of Pennsylvania
- Conditions
- Blepharospasm of Both Eyelids, Blepharospasm of Left Eyelid, Blepharospasm of Right Eyelid, Blepharospasm, Benign Essential, Blepharospasm
- Interventions
- Botulinum Neurotoxin Type A
- First posted
- 2026-03-24
- Last updated
- 2026-09-29
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | First time to retreatment | Outcome will be assessed during Visit 5 (2nd study injection visit) and reported at study conclusion. Visit 5 will take place for each individual subject between days 180 and 280. | Time to retreatment (in days) with DAXI between the first and second study injection cycle. |
| Primary | Final time to retreatment | Outcome will be assessed during Visit 7 (3rd study injection visit) and reported at study conclusion. Visit 7 will take place for each individual study subject between days 270 and 280. | For patients who receive 3 study injection cycles with DAXI over 12 months, a second primary endpoint will be the time to retreatment (in days) between the second-to-last and last injection cycle (i.e., between DAXI cycles 2 and 3). |
| Secondary | Difference in time to return of symptoms after first DAXI cycle | Outcome will be assessed during Visit 3 (1st study injection visit) and reported at study conclusion. Visit 3 will take place for each individual study subject between days 90 and 100. | Change in time (in days) to return of baseline blepharospasm symptoms, as documented in the Blepharospasm Severity Tracker Form between data relating to the last clinical injection cycle prior to screening and the first DAXI study injection cycle. |
| Secondary | Difference in time to return of symptoms after final DAXI cycle | Outcome will be assessed during Visit 5 (days 180-280) for subjects only receiving 2 injections during study participation, and during Visit 7 (days 270-280) for subjects receiving 3. Outcomes will be reported at study conclusion. | Change in time (in days) to return of baseline BSP symptoms, as documented in the Blepharospasm Severity Tracker Form between data relating to the last clinical injection cycle prior to screening and the last DAXI study injection cycle. |
| Secondary | Change in severity after first DAXI injection cycle | Outcome will be assessed during Visit 4 (1st study injection peak effect assessment) and reported at study conclusion. Visit 4 will take place for each individual study subject between days 114 and 156. | Change in the Blepharospasm Severity Rating Scale (BSRS) total score between Visit 2 (peak efficacy assessment of last clinical injection) and Visit 4 (peak efficacy assessment of first DAXI injection). The BSRS is a validated scale with scores ranging from 0 to 18, with higher numbers reflecting worsening blepharospasm severity. |
| Secondary | Change in severity after final DAXI injection cycle | BSRS will be assessed during Visit 6 (days 200-340) for subjects only receiving 2 injections during study participation, and during Visit 8 (days 294-336) for subjects receiving 3. Outcomes will be reported at study conclusion. | Change in Blepharospasm Severity Rating Scale (BSRS) total score between Visit 2 (the peak efficacy assessment of the last clinical injection) and the peak efficacy assessment following the subject's final DAXI study injection (which may occur during either the second or third injection cycle, depending on how long the individual subject chooses to wait before reinjection with DAXI). The BSRS is a validated scale ranging from 0 to 18, with higher scores indicating greater blepharospasm severity. |
| Secondary | First change in the Patient Global Impression of Change (PGIC) | Outcome will be assessed during Visit 4 (peak efficacy assessment of first study DAXI injection) taking place on days 114-156, and reported at study conclusion. | Change in Patient Global Impression of Change (PGIC) score between V2 (peak efficacy assessment of last clinical injection) and V4 (peak efficacy assessment of first study DAXI injection). The PGIC is a patient-reported outcome that acts as a 7-point Likert scale, with values ranging from -3 (very much worse) to +3 (very much better). |
| Secondary | Final change in the Patient Global Impression of Change (PGIC) | PGIC will be assessed during Visit 6 (days 200-340) for subjects only receiving 2 injections during study participation, and during Visit 8 (days 294-336) for subjects receiving 3. Outcomes will be reported at study conclusion. | Change in Patient Global Impression of Change (PGIC) score between V2 (peak efficacy assessment of last clinical injection) and during the peak efficacy assessment of the study subject's final DAXI study injection (which may occur during either the second or third injection cycle, depending on how long the individual subject chooses to wait before reinjection with DAXI). The PGIC is a patient-reported outcome that acts as a 7-point Likert scale, with values ranging from -3 (very much worse) to +3 (very much better). |
| Secondary | First change in the Clinical Global Impression of Change (CGIC) | Outcome will be assessed during Visit 4 (peak efficacy assessment of first study DAXI injection) taking place on days 114-156, and reported at study conclusion. | Change in Clinical Global Impression of Change (CGIC) score between V2 (peak efficacy assessment of last clinical injection) and V4 (peak efficacy assessment of first DAXI injection). The CGIC is a validated clinical outcome measure that acts as a 7-point Likert scale, with values ranging from -3 (very much worse) to +3 (very much better). |
| Secondary | Final change in the Clinical Global Impression of Change (CGIC) | CGIC will be assessed during Visit 6 (days 200-340) for subjects only receiving 2 injections during study participation, and during Visit 8 (days 294-336) for subjects receiving 3. Outcomes will be reported at study conclusion. | Change in Clinical Global Impression of Change (CGIC) score between V2 (peak efficacy assessment of last clinical injection) and during the peak efficacy assessment of the study subject's final DAXI study injection (which may occur during either the second or third injection cycle, depending on how long the individual subject chooses to wait before reinjection with DAXI). The CGIC is a validated clinical outcome measure that acts as a 7-point Likert scale, with values ranging from -3 (very much worse) to +3 (very much better). |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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.
Papers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT07489430
GET https://conductscience.org/api/trials/v1/NCT07489430/registered