Trial · NCT07489430
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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). |
| Secondary | First change in satisfaction | Outcome will be assessed during Visit 5 (days 180-280). Outcomes will be reported at study conclusion. | Change in Treatment Satisfaction Questionnaire score between V3 (day of first DAXI study injection) and V5 (day of second DAXI study injection). The Treatment Satisfaction Questionnaire is a patient-reported outcome that acts as a 7-point Likert scale, with values ranging from -3 (very dissatisfied) to +3 (very satisfied). |
| Secondary | Final change in satisfaction | Outcome will be assessed during Visit 7 (days 270-280) and Visit 9 (days 365-460). Outcomes will be reported at study conclusion. | Change in Treatment Satisfaction Questionnaire (TSQ) score between V3 (day of first DAXI study injection) and EOS/ET (last day of study). The Treatment Satisfaction Questionnaire is a patient-reported outcome that acts as a 7-point Likert scale, with values ranging from -3 (very dissatisfied) to +3 (very satisfied). |
| Secondary | Incidence of Treatment-Emergent Adverse Events (suicidality, toxin-related side effects and injection site reactions) | Outcomes will be assessed during Visit 1 (day 0), Visit 2 (day 30 +/-5), Visit 3 (day 95 +/-5), Visit 4 (day 135 +/- 21), Visit 5 (day 180-280), Visit 6 (day 200-340), Visit 7 (day 275 +/-5), Visit 8 (day 315 +/- 21), Visit 9 (day 365-460). | Safety, which includes screening for suicidality (C-SSRS) and adverse events (AEs), particularly adverse events of special interest: diplopia (or other visual disturbances), dry eyes, ptosis, injection site reactions and toxin effect spread to the lower face. |
| Other | First change in craniocervical dystonia questionnaire | 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 Craniocervical dystonia questionnaire (CDQ-24) total score between V2 (peak efficacy assessment of last clinical injection) and V4 (peak efficacy assessment of first DAXI injection). The CDQ-24 is a validated scale that tracks patient-reported outcomes, with scores ranging from 0 to 96. Higher scores indicate worsening dystonia symptoms. |
| Other | Final change in craniocervical questionnaire | Outcome 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 Craniocervical dystonia questionnaire (CDQ-24) total score between V2 (peak efficacy assessment of 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 CDQ-24 is a validated scale that tracks patient-reported outcomes, with scores ranging from 0 to 96. Higher scores indicate worsening dystonia symptoms. |
| Other | Average total DAXI doses at first and final study 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. | Average total dose in units (with standard deviation) of daxibotulinumtoxinA for each of the different facial muscles injected during the first and last study injection cycle. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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