Trial · NCT03543150
BOTOX® Drug Use Investigation (Spasmodic Dysphonia)
NCT03543150, Unknown, GlaxoSmithKline
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BOTOX® Drug Use Investigation (Spasmodic Dysphonia). Trials, record NCT03543150. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03543150
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BOTOX® Drug Use Investigation (Spasmodic Dysphonia)
- NCT number
- NCT03543150
- Status
- Unknown
- Enrollment
- 400 participants, estimated
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Dysphonia
- Interventions
- BOTOX
- First posted
- 2018-06-01
- Last updated
- 2021-10-07
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of subjects with adverse drug reactions | Up to 1 year | The investigator will collect the information about all adverse drug reactions including diseases and symptoms, occurring after the first administration of Botox, regardless of whether they are related to BOTOX. |
| Primary | Change from Baseline in voice handicap index (VHI)-10 scores | Baseline and up to 1 year | The VHI is a 30-item questionnaire divided into 3 subsections including functional, physical, and emotional which measures the effect of voice problems on quality of life. Subjects will mark each item on this 30-item questionnaire on a scale ranging from 0-4 (0 being never and 4 being always). Points for each subscale are tallied and a total composite score is also given. A total score of 0-11 is considered normal, 12-28 is considered mild minimal handicap, 29-56 is considered moderate handicap, and 57-120 is considered severe handicap. |
| Primary | Efficacy rate based on global assessment of efficacy | Up to 1 year | The efficacy rate is the number of subjects assessed as "effective" based on the course of subjective symptoms and clinical symptoms during the observation period from the date of the first administration of BOTOX injections. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37755979 | DERIVED |
Source PubMed
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/NCT03543150
GET https://conductscience.org/api/trials/v1/NCT03543150/registered