Trial · NCT05158166
DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia
NCT05158166, Phase 1, Phase 2, Completed, University of California, San Francisco
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia. Trials, record NCT05158166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05158166
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia
- NCT number
- NCT05158166
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Adductor Spasmodic Dysphonia, Voice Disorders, Spasmodic Dysphonia
- Interventions
- DaxibotulinumtoxinA
- First posted
- 2021-12-15
- Last updated
- 2026-05-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Our Primary Outcome is the Difference in VHI-10 Score at 30 Days After Injection With DAXI. | 30 days | 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. |
| Secondary | A Secondary Outcome Will be Comparing the Duration of Effect of DAXI With Patients' Prior Botox Treatment. | Up to 1 year | 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. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers5
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/NCT05158166
GET https://conductscience.org/api/trials/v1/NCT05158166/registered