Trial · NCT03292458
Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor
NCT03292458, Phase 2, Phase 3, Completed, Kristina Simonyan; results first posted 2025-04-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor. Trials, record NCT03292458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03292458
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor
- NCT number
- NCT03292458
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 117 participants, actual
- Lead sponsor
- Kristina Simonyan
- Conditions
- Spasmodic Dysphonia, Voice Tremor
- Interventions
- Sodium Oxybate
- First posted
- 2017-09-25
- Last updated
- 2025-12-30
- Results first posted
- 2025-04-04
- Limitations and caveats
A single-center trial: However, the patients were recruited across the US, the UK, and Australia, thus expanding the generalizability of the findings.~An inclusion of a greater number of Non-Hispanic White females: LD is well-documented to affect the Non-Hispanic White population with a 4:1 female to male prevalence. Thus, the demographics of patients recruited for this trial reflect the clinical demographics of the disorder in general.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Symptom Severity | 40 min after drug or placebo administration | A combined clinician-objective and patient-subjective change in visual analog scale (min-max 0-100, a higher score is the worse outcome) score of symptom severity before and after drug vs. placebo intake. For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group. For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group. |
| Primary | Minimum Treatment Efficacy | 40 min after drug or placebo administration | Pre-specified to analysis based only on alcohol responsiveness (EtOH+). A combined clinician-objective and patient-subjective change in visual analog scale score (min-max 0-100, a higher score is the worse outcome) of symptom severity in EtOH+ patients. |
| Secondary | Treatment Efficacy Dependent on LD Clinical Type | 40 min after drug or placebo administration | A combined clinician-objective and patient-subjective change in visual analog scale (min-max 0-100, a higher score is the worse outcome) score of symptom severity before and after drug vs. placebo intake. EtOH+ and EtOH- were stratified based on phenotypical characteristics, including LD, LD with Dystonic Tremor of Voice, Abductor LD, Adductor LD. |
| Secondary | Length of Treatment Efficacy | 40 min to 5 hours after drug or placebo administration | The length of treatment efficacy in each EtOH+ and EtOH- group was assessed at 40, 180, and 300 min after drug vs. placebo intake compared to the baseline using a combined clinician-objective and patient-subjective change in visual analog scale (min-max 0-100, a higher score is the worse outcome) score of symptom severity. For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group. For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group. |
| Secondary | Relationship Between Alcohol-responsiveness of Symptoms and Drug-induced Symptom Improvement | 40 min after drug or placebo administration | A combined clinician-objective and patient-subjective change in visual analog scale (min-max 0-100, a higher score is the worse outcome) score of symptom severity before and 40 min after drug vs. placebo intake. For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group. For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group. |
| Secondary | Relationship Between Symptom Severity Change and Dystonia Clinical Characteristics | 40 min after drug or placebo administration | A combined clinician-objective and patient-subjective change in visual analog scale (min-max 0-100, a higher score is the worse outcome) score of symptom severity before and 40 min after drug vs. placebo intake. For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group. For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Symptom Severity | 40 min after drug or placebo administration | score on a scale | LEAST_SQUARES_MEAN | |
| PRIMARY | Minimum Treatment Efficacy | 40 min after drug or placebo administration | Pre-specified to only report Alcohol-responsive (EtOH+) Laryngeal Dystonia Arm | percentage of symptom change | MEAN |
| SECONDARY | Treatment Efficacy Dependent on LD Clinical Type | 40 min after drug or placebo administration | score on a scale | MEAN | |
| SECONDARY | Length of Treatment Efficacy | 40 min to 5 hours after drug or placebo administration | Pre-specified to only report based on alcohol-responsiveness (EtOH+, EtOH-) | score on a scale | MEAN |
| SECONDARY | Relationship Between Alcohol-responsiveness of Symptoms and Drug-induced Symptom Improvement | 40 min after drug or placebo administration | Pre-specified to only report based on alcohol-responsiveness (EtOH+, EtOH-) | correlation coefficient | NUMBER |
| SECONDARY | Relationship Between Symptom Severity Change and Dystonia Clinical Characteristics | 40 min after drug or placebo administration | Pre-specified to only report based on alcohol-responsiveness (EtOH+, EtOH-) | correlation coefficient | NUMBER |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Symptom Severity | Alcohol-responsive (EtOH+) Laryngeal Dystonia | Sodium oxybate | 28.0 | 98.75% Confidence Interval 21.0 to 35.0 | score on a scale |
| Symptom Severity | Alcohol-non-responsive (EtOH-) Laryngeal Dystonia | Sodium oxybate | 18.6 | 98.75% Confidence Interval 12.0 to 25.2 | score on a scale |
| Symptom Severity | Alcohol-responsive (EtOH+) Laryngeal Dystonia | Placebo | 14.2 | 98.75% Confidence Interval 7.2 to 21.2 | score on a scale |
| Symptom Severity | Alcohol-non-responsive (EtOH-) Laryngeal Dystonia | Placebo | 12.3 | 98.75% Confidence Interval 5.7 to 19.0 | score on a scale |
| Minimum Treatment Efficacy | Alcohol-responsive (EtOH+) Laryngeal Dystonia | Symptom improvement ≥ 16% | 40.81 | 98.75% Confidence Interval 34.7 to 48.6 | percentage of symptom change |
| Minimum Treatment Efficacy | Alcohol-responsive (EtOH+) Laryngeal Dystonia | Symptom improvement < 16% | 4.76 | 98.75% Confidence Interval 1.1 to 8.1 | percentage of symptom change |
| Treatment Efficacy Dependent on LD Clinical Type | Alcohol-responsive (EtOH+) Laryngeal Dystonia | Sodium oxybate | 24.65 | Standard Error 4.45 | score on a scale |
| Treatment Efficacy Dependent on LD Clinical Type | Alcohol-responsive (EtOH+) Laryngeal Dystonia With Dystonic Tremor of Voice | Sodium oxybate | 30.54 | Standard Error 4.29 | score on a scale |
| Treatment Efficacy Dependent on LD Clinical Type | Alcohol-non-responsive (EtOH-) Laryngeal Dystonia | Sodium oxybate | 18.30 | Standard Error 3.07 | score on a scale |
| Treatment Efficacy Dependent on LD Clinical Type | Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of Voice | Sodium oxybate | 18.96 | Standard Error 3.49 | score on a scale |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Laryngeal Dystonia With and Without Dystonic Tremor of Voice: Sodium Oxybate, Then Placebo | 55 | |
| Period 1 | STARTED | Laryngeal Dystonia With and Without Dystonic Tremor of Voice: Placebo, Then Sodium Oxybate | 53 | |
| Period 1 | COMPLETED | Laryngeal Dystonia With and Without Dystonic Tremor of Voice: Sodium Oxybate, Then Placebo | 53 | |
| Period 1 | COMPLETED | Laryngeal Dystonia With and Without Dystonic Tremor of Voice: Placebo, Then Sodium Oxybate | 53 | |
| Period 1 | NOT COMPLETED | Laryngeal Dystonia With and Without Dystonic Tremor of Voice: Sodium Oxybate, Then Placebo | 2 | |
| Period 1 | NOT COMPLETED | Laryngeal Dystonia With and Without Dystonic Tremor of Voice: Placebo, Then Sodium Oxybate | 0 | |
| Period 2 | STARTED | Laryngeal Dystonia With and Without Dystonic Tremor of Voice: Sodium Oxybate, Then Placebo | 53 | |
| Period 2 | STARTED | Laryngeal Dystonia With and Without Dystonic Tremor of Voice: Placebo, Then Sodium Oxybate | 53 | |
| Period 2 | COMPLETED | Laryngeal Dystonia With and Without Dystonic Tremor of Voice: Sodium Oxybate, Then Placebo | 53 | |
| Period 2 | COMPLETED | Laryngeal Dystonia With and Without Dystonic Tremor of Voice: Placebo, Then Sodium Oxybate | 53 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events76
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mild Dizziness/ lightheadedness/unsteadiness/clumsiness | Nervous system disorders | Sodium Oxybate: Alcohol-responsive (EtOH+) Laryngeal Dystonia | 24 | 50 | |
| other | Mild Dizziness/ lightheadedness/unsteadiness/clumsiness | Nervous system disorders | Placebo: Alcohol-responsive (EtOH+) Laryngeal Dystonia | 4 | 50 | |
| other | Mild Dizziness/ lightheadedness/unsteadiness/clumsiness | Nervous system disorders | Sodium Oxybate: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia | 27 | 56 | |
| other | Mild Dizziness/ lightheadedness/unsteadiness/clumsiness | Nervous system disorders | Placebo: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia | 8 | 56 | |
| other | Mild Blurred vision | Nervous system disorders | Sodium Oxybate: Alcohol-responsive (EtOH+) Laryngeal Dystonia | 2 | 50 | |
| other | Mild Blurred vision | Nervous system disorders | Placebo: Alcohol-responsive (EtOH+) Laryngeal Dystonia | 1 | 50 | |
| other | Mild Blurred vision | Nervous system disorders | Sodium Oxybate: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia | 4 | 56 | |
| other | Mild Blurred vision | Nervous system disorders | Placebo: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia | 0 | 56 | |
| other | Mild Headache | Nervous system disorders | Sodium Oxybate: Alcohol-responsive (EtOH+) Laryngeal Dystonia | 4 | 50 | |
| other | Mild Headache | Nervous system disorders | Placebo: Alcohol-responsive (EtOH+) Laryngeal Dystonia | 2 | 50 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sodium Oxybate: Alcohol-responsive (EtOH+) Laryngeal Dystonia | 0 | 50 |
| Total, all-cause mortality | Placebo: Alcohol-responsive (EtOH+) Laryngeal Dystonia | 0 | 50 |
| Total, all-cause mortality | Sodium Oxybate: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia | 0 | 56 |
| Total, all-cause mortality | Placebo: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia | 0 | 56 |
| Total, other adverse events | Sodium Oxybate: Alcohol-responsive (EtOH+) Laryngeal Dystonia | 29 | 50 |
| Total, other adverse events | Placebo: Alcohol-responsive (EtOH+) Laryngeal Dystonia | 8 | 50 |
| Total, other adverse events | Sodium Oxybate: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia | 37 | 56 |
| Total, other adverse events | Placebo: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia | 13 | 56 |
| Total, serious adverse events | Sodium Oxybate: Alcohol-responsive (EtOH+) Laryngeal Dystonia | 0 | 50 |
| Total, serious adverse events | Placebo: Alcohol-responsive (EtOH+) Laryngeal Dystonia | 0 | 50 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers7
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DC012545 | Central mechanisms and treatment response of sodium oxybate in spasmodic dysphonia and voice tremor | SIMONYAN, KRISTINA | MASSACHUSETTS EYE AND EAR INFIRMARY | NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS | 2012 to 2021 |
Source NIH RePORTER
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/NCT03292458
GET https://conductscience.org/api/trials/v1/NCT03292458/results?page=2