Trial Outcomes & Findings for DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia (NCT NCT05158166)
NCT ID: NCT05158166
Last Updated: 2026-05-18
Results Overview
The Voice Handicap Index-10 (VHI-10) is a patient-reported questionnaire (range 0-40) that measures voice-related handicap, with higher scores indicating greater severity. Difference between baseline and 30 days post DAXI injection scores will be determined using a paired t-test with subjects pre-treatment VHI-10 scores as a control.
COMPLETED
PHASE1/PHASE2
22 participants
30 days
2026-05-18
Participant Flow
Participant milestones
| Measure |
Administration of Daxi
Injectible daxibotulinumtoxinA (DAXI, Revance Therapeutics Inc., Newark, CA) is an investigational botulinum toxin type A which has been shown in large clinical trials to provide safe, effective treatment for glabellar lines and cervical dystonia and may offer longer-lasting results when compared with onabotulinumtoxinA. Dosage will be same number of units as prior Botox A dose.
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Overall Study
STARTED
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22
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Overall Study
COMPLETED
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22
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia
Baseline characteristics by cohort
| Measure |
Administration of Daxi
n=20 Participants
Injectible daxibotulinumtoxinA (DAXI, Revance Therapeutics Inc., Newark, CA) is an investigational botulinum toxin type A which has been shown in large clinical trials to provide safe, effective treatment for glabellar lines and cervical dystonia and may offer longer-lasting results when compared with onabotulinumtoxinA. Dosage will be same number of units as prior Botox A dose.
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Age, Continuous
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58.3 Years
n=11 Participants
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Sex: Female, Male
Female
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15 Participants
n=11 Participants
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Sex: Female, Male
Male
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5 Participants
n=11 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=11 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=11 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=11 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=11 Participants
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Race (NIH/OMB)
White
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18 Participants
n=11 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=11 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=11 Participants
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VHI-10
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21.10 units on a scale
STANDARD_DEVIATION 6.82 • n=11 Participants
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PRIMARY outcome
Timeframe: 30 daysPopulation: Two patients had no change in their voice and no swallowing impact. These patients were thus considered "misses," or injection events that did not reach the intended TA-LCA muscle complexes and thus were not included in the subsequent analysis.
The Voice Handicap Index-10 (VHI-10) is a patient-reported questionnaire (range 0-40) that measures voice-related handicap, with higher scores indicating greater severity. Difference between baseline and 30 days post DAXI injection scores will be determined using a paired t-test with subjects pre-treatment VHI-10 scores as a control.
Outcome measures
| Measure |
Administration of Daxi
n=20 Participants
Injectible daxibotulinumtoxinA (DAXI, Revance Therapeutics Inc., Newark, CA) is an investigational botulinum toxin type A which has been shown in large clinical trials to provide safe, effective treatment for glabellar lines and cervical dystonia and may offer longer-lasting results when compared with onabotulinumtoxinA. Dosage will be same number of units as prior Botox A dose.
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Our Primary Outcome is the Difference in VHI-10 Score at 30 Days After Injection With DAXI.
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17.81 units on a scale
Standard Deviation 8.18
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Two patients had no change in their voice and no swallowing impact. These patients were thus considered "misses," or injection events that did not reach the intended TA-LCA muscle complexes and thus were not included in the subsequent analysis. The overall cohort was split into three subgroups based on their Duration of Voice Benefit (DVB) with DAXI and Botox (BtxA) for statistical analysis: Group A (DVB DAXI\>BtxA), Group B (DVB DAXI=BtxA), and Group C (DVB DAXI\<BtxA)
Duration of Voice Benefit (DVB) was determined by calculating the difference of time (in days) between injection date and time the patient reported a significant reduction of benefit that would prompt scheduling a repeat treatment. DVB is routinely calculated for all Adductor-type laryngeal dystonia (AdLD) patients during their return visits by asking "how many days ago did you lose injection benefit such that you felt you needed another injection." This time frame was then subtracted from the number of days between injection dates to calculate DVB. For Botox (BtxA), a mean DVB was calculated by averaging the last three DVB values from successful injections to compare to the Daxi DVB. Clinically significant difference in DVB was a priori determined as \> 14 days between values to allow for normal inter-injection variability.
Outcome measures
| Measure |
Administration of Daxi
n=20 Participants
Injectible daxibotulinumtoxinA (DAXI, Revance Therapeutics Inc., Newark, CA) is an investigational botulinum toxin type A which has been shown in large clinical trials to provide safe, effective treatment for glabellar lines and cervical dystonia and may offer longer-lasting results when compared with onabotulinumtoxinA. Dosage will be same number of units as prior Botox A dose.
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A Secondary Outcome Will be Comparing the Duration of Effect of DAXI With Patients' Prior Botox Treatment.
Group A (DVB DAXI>BtxA) Mean DVB for Daxi
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130.6 days
Interval 34.0 to 179.0
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A Secondary Outcome Will be Comparing the Duration of Effect of DAXI With Patients' Prior Botox Treatment.
Group A (DVB DAXI>BtxA) Mean DVB for BtxA
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86.1 days
Interval 51.0 to 111.0
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A Secondary Outcome Will be Comparing the Duration of Effect of DAXI With Patients' Prior Botox Treatment.
Group B (DVB DAXI=BtxA) Mean DVB for Daxi
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86.86 days
Interval 69.0 to 118.0
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A Secondary Outcome Will be Comparing the Duration of Effect of DAXI With Patients' Prior Botox Treatment.
Group B (DVB DAXI=BtxA) Mean DVB for BtxA
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83.29 days
Interval 70.0 to 111.0
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A Secondary Outcome Will be Comparing the Duration of Effect of DAXI With Patients' Prior Botox Treatment.
Group C (DVB DAXI<BtxA) Mean DVB for DAXI
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49.8 days
Interval 37.0 to 66.0
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A Secondary Outcome Will be Comparing the Duration of Effect of DAXI With Patients' Prior Botox Treatment.
Group C (DVB DAXI<BtxA) Mean DVB for BtxA
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81.8 days
Interval 52.0 to 92.0
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Adverse Events
Administration of Daxi
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place