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CompletedNCT03292458Updated Dec 30, 2025Results posted

Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor

A Phase 2/3 interventional study of Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor, sponsored by Kristina Simonyan. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by Kristina Simonyan · Phase 2/3, Interventional, and Basic science

Phase
Phase 2/3
Study type
Interventional
Enrollment
117
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 71 studies in Dysphonia with a site in United States — 20 open to participants now, 21 under way, 1 of them phase 3. Dysphonia · United States.

Enrollment
11th of 53
117 · median 32
Started
2018
with 2 others
Phase 2/3
2 of 71
none open now
Registered
29th of 71
by date
Lead sponsor
5 of 71
Kristina Simonyan

Among the 71 studies in Dysphonia with a site in United States, this one is the 11th largest by enrollment of the 53 interventional ones, is one of 3 that started in 2018, is one of 2 in phase 2/3, and was the 29th registered.

By phase

71 studies; the count open now beside each. This study's row is marked.

No phase31 · 12 open
Observational18 · 4 open
Phase 1/25 · 0 open
Phase 45 · 1 open
Phase 14 · 2 open
Phase 24 · 0 open
Phase 2/3this study2 · 0 open
Phase 32 · 1 open

By the year they started

First in 1992; this study’s year is marked. 3 started in 2018.

Size and results

Median enrollment 32 across the 53 interventional studies, 170 across the 18 observational. Of the 41 that completed or were terminated, 17 (41%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 71 studies in Dysphonia with a site in United States, or all of them as a file.
02

Study summary

Using a comprehensive approach of clinico-behavioral testing, neuroimaging and pharmacogenetics, the researchers will examine the clinical effects of sodium oxybate and the matched placebo on voice symptoms in spasmodic dysphonia and voice tremor.

Read the detailed description

Spasmodic dysphonia (SD), or laryngeal dystonia, is a chronic debilitating condition that selectively affects speech production due to involuntary spasms in the laryngeal muscles. SD often extends beyond the impairment of vocal communication causing significant occupational disability and life-long social isolation. SD becomes even more incapacitating when it is associated with dystonic voice tremor (VT), which is present in about 1/3 of SD patients and is characterized by the inability to sustain a vowel for more than a few seconds. Current treatment of these disorders is limited to the temporary management of voice symptoms with repeated injections of botulinum toxin into the laryngeal muscles. These injections, however, are not fully effective in all SD patients and even less so in combined SD and VT cases. There is, therefore, a critical need to identify alternative therapeutic options that specifically target the pathophysiology of these disorders. On the other hand, the design and the use of such novel therapeutic approaches will be largely unattainable if their central mechanisms of action remain unknown. The objective of this study is to elucidate the primary determinants of clinical response to a novel oral medication, sodium oxybate (Xyrem®), in alcohol-responsive SD and VT patients. Using a comprehensive approach of clinico-behavioral testing, neuroimaging and pharmacogenetics, we aim to determine the clinical response of SD and VT symptoms to sodium oxybate and identify the primary markers of its clinical benefits. This study will use a controlled experimental design that focuses on detailed characterization of primary effects of a novel oral medication, sodium oxybate, for treatment of SD and VT symptoms.

03

Conditions studied

  • Spasmodic Dysphonia
  • Voice Tremor

Browse trials for

Keywords

  • spasmodic dysphonia
  • laryngeal dystonia
  • functional MRI
  • Xyrem
04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with SD and combined SD and VT will have a clinically documented adductor or abductor form of disorder, either with or without positive effects of alcohol on their voice symptoms;
  2. Healthy controls will be healthy volunteers with a negative history of laryngeal, neurological, or psychiatric problems (existing neuroimaging data will be used);
  3. Age from 21 to 80 years.
  4. Native English speakers.
  5. Right-handedness (based on Edinburgh Handedness Inventory).

Exclusion criteria

Exclusion Criteria:

  1. Subjects who are incapable of giving an will be excluded from the study.
  2. Pregnant and breastfeeding women until a time when they are no longer pregnant or breastfeeding will be excluded from the study. All patients of will be required to agree to use a reliable method of prior to and during the study. The method of contraception will be documented in the patient's research chart. All women of childbearing potential will undergo a urine pregnancy test, which must be negative for study participation.

  3. All patients with a past or present history of the following conditions will be excluded from the study;

    1. Except for SD and dystonic VT, any neurological disorders, such as stroke, movement disorders, brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug dependence. Patients with tremor affecting other body parts will be excluded from the study. All patients who have dystonic movements in the body regions other than the larynx will be excluded from the study. This will allow maintaining the homogenous patient population and evaluating central drug effects without confounding by the presence of other neurological conditions.
    2. Any psychiatric problems, such as schizophrenia, major and/or bipolar depression, obsessive-compulsive disorder, will be excluded to maintain the homogenous patient population and allow for the evaluation of central drug effect without confounding by the presence of psychiatric conditions.
    3. Any laryngeal problems, such as vocal fold paralysis, paresis, carcinoma, chronic laryngitis, will be excluded from the study.
    4. Patients with a known past or present history of grade 2 or higher hepatic and renal dysfunction according to the NCI criteria will be excluded.
    5. Patients with a known past or present history of moderate to severe congestive heart failure will be excluded.
    6. Patients with a known past or present history of cognitive impairment and active suicidal ideations will be excluded.
  4. Patients who are not symptomatic due to treatment with botulinum toxin injections into the laryngeal muscles will be excluded from the study until the time when they are fully symptomatic. The duration of positive effects of botulinum toxin vary from patient to patient, lasting on average 3-4 months. All patients will be evaluated to ensure that they are fully symptomatic prior to the entering the study.
  5. To avoid the possibility of confounding effects of drugs acting upon the central nervous system, all patients will be questioned about any prescribed or over-the-counter medications as part of their initial intake screening. Those patients who receive medication(s) affecting the central nervous system (except for sodium oxybate) will be excluded from the study.
  6. Patients will be asked whether they have undergone any head and neck surgeries, particularly any brain surgery and laryngeal surgeries, such as thyroplasty, laryngeal denervation, and selective laryngeal adductor denervation-reinnervation. Because both brain and laryngeal surgery may potentially lead to the brain structure and function re-organization, all subjects with a history of brain and/or laryngeal surgery will be excluded from the study.
  7. Patients who have tattoos, ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve, etc.) that are not MRI comparable and/or cannot be removed for the purpose of MRI study participation will be excluded from the study.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
117 participants (actual)

Study arms

  • Experimental
    Clinical response to sodium oxybate

    In contrast to placebo but similar to alcohol, sodium oxybate is expected to be most effective in reducing voice symptoms in alcohol-responsive SD and VT.

    Drug: Sodium Oxybate

  • Experimental
    Central markers of clinical response

    The clinical outcome is expected to be determined by selective modulation of functional abnormalities in the brain regions controlling speech sensorimotor processing and integration in association with underlying gene variants.

    Drug: Sodium Oxybate

Interventions

  • DrugSodium Oxybate

    Alcohol challenge test and oral administration of a single dose of sodium oxybate and the matching placebo.

    Also known as: Placebo, Alcohol

06

What researchers measure

Primary outcomes

  1. Symptom Severity

    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.

    Time frame: 40 min after drug or placebo administration

  2. Minimum Treatment Efficacy

    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.

    Time frame: 40 min after drug or placebo administration

Secondary outcomes

  1. Treatment Efficacy Dependent on LD Clinical Type

    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.

    Time frame: 40 min after drug or placebo administration

  2. Length of Treatment Efficacy

    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.

    Time frame: 40 min to 5 hours after drug or placebo administration

  3. Relationship Between Alcohol-responsiveness of Symptoms and Drug-induced Symptom Improvement

    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.

    Time frame: 40 min after drug or placebo administration

  4. Relationship Between Symptom Severity Change and Dystonia Clinical Characteristics

    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.

    Time frame: 40 min after drug or placebo administration

07

Results

Posted Apr 4, 2025
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.

Participant flow

The study was conducted between January 22, 2018, and December 29, 2021. The COVID-19 pandemic and the associated lockdown of human research activities fully paused patient recruitment and the conduct of study procedures between March 2020 and December 2020.

Period 1
Participant flow — Period 1
MilestoneLaryngeal Dystonia With and Without Dystonic Tremor of Voice: Sodium Oxybate, Then PlaceboLaryngeal Dystonia With and Without Dystonic Tremor of Voice: Placebo, Then Sodium Oxybate
Started5553
Completed5353
Not completed20
Withdrew: Adverse event20
Period 2
Participant flow — Period 2
MilestoneLaryngeal Dystonia With and Without Dystonic Tremor of Voice: Sodium Oxybate, Then PlaceboLaryngeal Dystonia With and Without Dystonic Tremor of Voice: Placebo, Then Sodium Oxybate
Started5353
Completed5353
Not completed00

Outcome measures

PrimarySymptom Severity

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.

Time frame:
40 min after drug or placebo administration
Reported as:
Least squares mean · score on a scale
Symptom Severity
score on a scaleAlcohol-responsive (EtOH+) Laryngeal DystoniaAlcohol-non-responsive (EtOH-) Laryngeal Dystonia
Sodium oxybate28.0 (21.0 to 35.0)18.6 (12.0 to 25.2)
Placebo14.2 (7.2 to 21.2)12.3 (5.7 to 19.0)
Statistical analysis
  • Alcohol-responsive (EtOH+) Laryngeal Dystonia vs Alcohol-non-responsive (EtOH-) Laryngeal Dystonia · Mixed Models Analysis · p = 0.01
PrimaryMinimum Treatment Efficacy

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.

Time frame:
40 min after drug or placebo administration
Reported as:
Mean · percentage of symptom change
Minimum Treatment Efficacy
percentage of symptom changeAlcohol-responsive (EtOH+) Laryngeal Dystonia
Symptom improvement ≥ 16%40.81 (34.7 to 48.6)
Symptom improvement < 16%4.76 (1.1 to 8.1)
Statistical analysis
  • Alcohol-responsive (EtOH+) Laryngeal Dystonia · Regression, Logistic · p = 0.05
SecondaryTreatment Efficacy Dependent on LD Clinical Type

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.

Time frame:
40 min after drug or placebo administration
Reported as:
Mean · score on a scale
Treatment Efficacy Dependent on LD Clinical Type
score on a scaleAlcohol-responsive (EtOH+) Laryngeal DystoniaAlcohol-responsive (EtOH+) Laryngeal Dystonia With Dystonic Tremor of VoiceAlcohol-non-responsive (EtOH-) Laryngeal DystoniaAlcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of VoiceAlcohol-responsive Adductor Type of Laryngeal DystoniaAlcohol-responsive Abductor Type of Laryngeal DystoniaAlcohol-non-responsive Adductor Type of Laryngeal DystoniaAlcohol-non-responsive Abductor Type of Laryngeal Dystonia
Sodium oxybate24.65 ± 4.4530.54 ± 4.2918.30 ± 3.0718.96 ± 3.4931.70 ± 5.0824.85 ± 3.9221.36 ± 2.8614.96 ± 4.04
Placebo18.07 ± 3.9910.85 ± 5.9010.34 ± 1.9414.47 ± 1.9313.59 ± 6.0713.10 ± 4.6213.07 ± 1.5411.32 ± 2.83
Statistical analysis
  • Alcohol-responsive (EtOH+) Laryngeal Dystonia vs Alcohol-responsive (EtOH+) Laryngeal Dystonia With Dystonic Tremor of Voice vs Alcohol-non-responsive (EtOH-) Laryngeal Dystonia vs Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of Voice vs Alcohol-responsive Adductor Type of Laryngeal Dystonia vs Alcohol-responsive Abductor Type of Laryngeal Dystonia vs Alcohol-non-responsive Adductor Type of Laryngeal Dystonia vs Alcohol-non-responsive Abductor Type of Laryngeal Dystonia · t-test, 2 sided · p = 0.01 · Mean difference (final values): 98.75
SecondaryLength of Treatment Efficacy

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.

Time frame:
40 min to 5 hours after drug or placebo administration
Reported as:
Mean · score on a scale
Length of Treatment Efficacy
score on a scaleAlcohol-responsive (EtOH+) Laryngeal DystoniaAlcohol-non-responsive (EtOH-) Laryngeal Dystonia
Sodium oxybate: 40 min28.0 ± 3.0618.60 ± 2.31
Sodium oxybate: 180 min18.63 ± 3.3612.67 ± 2.40
Sodium oxybate: 300 min15.47 ± 4.328.33 ± 1.98
Placebo: 40 min14.23 ± 3.7112.34 ± 1.39
Placebo: 180 min9.26 ± 3.619.31 ± 1.99
Placebo: 300 min10.30 ± 3.158.16 ± 1.84
Statistical analysis
  • Alcohol-responsive (EtOH+) Laryngeal Dystonia vs Alcohol-non-responsive (EtOH-) Laryngeal Dystonia · ANOVA · p = 0.01
SecondaryRelationship Between Alcohol-responsiveness of Symptoms and Drug-induced Symptom Improvement

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.

Time frame:
40 min after drug or placebo administration
Reported as:
Number · correlation coefficient
Relationship Between Alcohol-responsiveness of Symptoms and Drug-induced Symptom Improvement
correlation coefficientAlcohol-responsive (EtOH+) Laryngeal DystoniaAlcohol-non-responsive (EtOH-) Laryngeal Dystonia
Sodium oxybate0.45 (0.10 to 6.88)0.09 (-0.024 to 0.35)
Placebo0.06 (-0.034 to 0.39)0.22 (-0.10 to 0.55)
Statistical analysis
  • Alcohol-responsive (EtOH+) Laryngeal Dystonia vs Alcohol-non-responsive (EtOH-) Laryngeal Dystonia · Pearson correlation · p = 0.01
SecondaryRelationship Between Symptom Severity Change and Dystonia Clinical Characteristics

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.

Time frame:
40 min after drug or placebo administration
Reported as:
Number · correlation coefficient
Relationship Between Symptom Severity Change and Dystonia Clinical Characteristics
correlation coefficientAlcohol-responsive (EtOH+) Laryngeal DystoniaAlcohol-non-responsive (EtOH-) Laryngeal Dystonia
Sodium oxybate: duration-0.17 (-0.51 to 0.16)0.10 (-0.26 to 0.49)
Placebo: duration0.18 (-0.21 to 0.52)0.16 (-0.17 to 0.44)
Sodium oxybate: age of symptom onset0.16 (-0.14 to 0.47)-0.15 (-0.43 to 0.18)
Placebo: age of symptom onset-0.18 (-0.46 to 0.22)-0.09 (-0.40 to 0.30)
Sodium oxybate: baseline symptom severity-0.05 (-0.31 to 0.20)-0.04 (-0.47 to 0.36)
Placebo: baseline symptom severity0.24 (-0.20 to 0.58)-0.11 (-0.39 to 0.18)
Statistical analysis
  • Alcohol-responsive (EtOH+) Laryngeal Dystonia vs Alcohol-non-responsive (EtOH-) Laryngeal Dystonia · Pearson correlation · p = 0.01

Adverse events

Collected over 5 hours and a 24-hour follow-up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sodium Oxybate: Alcohol-responsive (EtOH+) Laryngeal Dystonia0/50 (0%)0/50 (0%)29/50 (58%)
Placebo: Alcohol-responsive (EtOH+) Laryngeal Dystonia0/50 (0%)0/50 (0%)8/50 (16%)
Sodium Oxybate: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia0/56 (0%)0/56 (0%)37/56 (66.1%)
Placebo: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia0/56 (0%)0/56 (0%)13/56 (23.2%)
Most frequent other events
Showing 10 of 19
Most frequent other events
EventSodium Oxybate: Alcohol-responsive (EtOH+) Laryngeal DystoniaPlacebo: Alcohol-responsive (EtOH+) Laryngeal DystoniaSodium Oxybate: Alcohol-non-responsive (EtOH-) Laryngeal DystoniaPlacebo: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
Mild Dizziness/ lightheadedness/unsteadiness/clumsinessNervous system disorders24/504/5027/568/56
Mild Daytime sleepinessNervous system disorders10/503/508/560/56
Mild NauseaGastrointestinal disorders1/500/508/561/56
Mild HeadacheNervous system disorders4/502/503/562/56
Mild Blurred visionNervous system disorders2/501/504/560/56
Mild Trouble concentratingNervous system disorders3/500/501/561/56
Mild Dry mouthGastrointestinal disorders3/503/503/561/56
Mild VomitingGastrointestinal disorders0/500/502/560/56
Moderate Dizziness/ lightheadedness/unsteadiness/clumsinessNervous system disorders1/500/502/560/56
Mild ConfusionNervous system disorders1/500/500/560/56

Baseline characteristics

Pre-specified to analysis based only on the diagnosis (LD, LD/DTv) and alcohol responsiveness (EtOH+, EtOH-).

Age, Categorical
Age, Categorical(Participants)(1) Alcohol-responsive (EtOH+) Laryngeal Dystonia(2) Alcohol-responsive (EtOH+) Laryngeal Dystonia With Dystonic Tremor of Voice(3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia(4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of VoiceTotal
<=18 years00000
Between 18 and 65 years1916231270
>=65 years41371438
Age, Continuous
Age, Continuous(years)(1) Alcohol-responsive (EtOH+) Laryngeal Dystonia(2) Alcohol-responsive (EtOH+) Laryngeal Dystonia With Dystonic Tremor of Voice(3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia(4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of VoiceTotal
Median56.0 (48.5 to 61.5)62.0 (52.0 to 68.0)57.0 (48.0 to 63.8)66.5 (54.3 to 71.8)59.5 (50.0 to 68.0)
Sex: Female, Male
Sex: Female, Male(Participants)(1) Alcohol-responsive (EtOH+) Laryngeal Dystonia(2) Alcohol-responsive (EtOH+) Laryngeal Dystonia With Dystonic Tremor of Voice(3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia(4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of VoiceTotal
Female1526171876
Male8313832
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)(1) Alcohol-responsive (EtOH+) Laryngeal Dystonia(2) Alcohol-responsive (EtOH+) Laryngeal Dystonia With Dystonic Tremor of Voice(3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia(4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of VoiceTotal
Hispanic or Latino00000
Not Hispanic or Latino23293026108
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)(1) Alcohol-responsive (EtOH+) Laryngeal Dystonia(2) Alcohol-responsive (EtOH+) Laryngeal Dystonia With Dystonic Tremor of Voice(3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia(4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of VoiceTotal
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American31127
White20282924101
More than one race00000
Unknown or Not Reported00000
Handedness
Handedness(Participants)(1) Alcohol-responsive (EtOH+) Laryngeal Dystonia(2) Alcohol-responsive (EtOH+) Laryngeal Dystonia With Dystonic Tremor of Voice(3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia(4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of VoiceTotal
Right-handed23293026108
Left-handed00000
Monolingual native English Language
Monolingual native English Language(Participants)(1) Alcohol-responsive (EtOH+) Laryngeal Dystonia(2) Alcohol-responsive (EtOH+) Laryngeal Dystonia With Dystonic Tremor of Voice(3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia(4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of VoiceTotal
Count of participants23293026108
Cognitive function
Cognitive function(Participants)(1) Alcohol-responsive (EtOH+) Laryngeal Dystonia(2) Alcohol-responsive (EtOH+) Laryngeal Dystonia With Dystonic Tremor of Voice(3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia(4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of VoiceTotal
≥ 26 points (normal cognitive function)23293026108
< 26 points (impaired cognitive function)00000

6 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Massachusetts Eye and Ear
    Boston, Massachusetts 02114, United States
09

References and documents

Publications

  • Simonyan K, Frucht SJ. Long-term Effect of Sodium Oxybate (Xyrem(R)) in Spasmodic Dysphonia with Vocal Tremor. Tremor Other Hyperkinet Mov (N Y). 2013 Dec 9;3:tre-03-206-4731-1. doi: 10.7916/D8CJ8C5S. eCollection 2013. PubMed 24386608 ↗
  • Rumbach AF, Blitzer A, Frucht SJ, Simonyan K. An open-label study of sodium oxybate in Spasmodic dysphonia. Laryngoscope. 2017 Jun;127(6):1402-1407. doi: 10.1002/lary.26381. Epub 2016 Nov 3. PubMed 27808415 ↗
  • Battistella G, Fuertinger S, Fleysher L, Ozelius LJ, Simonyan K. Cortical sensorimotor alterations classify clinical phenotype and putative genotype of spasmodic dysphonia. Eur J Neurol. 2016 Oct;23(10):1517-27. doi: 10.1111/ene.13067. Epub 2016 Jun 27. PubMed 27346568 ↗
  • Kirke DN, Battistella G, Kumar V, Rubien-Thomas E, Choy M, Rumbach A, Simonyan K. Neural correlates of dystonic tremor: a multimodal study of voice tremor in spasmodic dysphonia. Brain Imaging Behav. 2017 Feb;11(1):166-175. doi: 10.1007/s11682-016-9513-x. PubMed 26843004 ↗
  • Kirke DN, Frucht SJ, Simonyan K. Alcohol responsiveness in laryngeal dystonia: a survey study. J Neurol. 2015 Jun;262(6):1548-56. doi: 10.1007/s00415-015-7751-2. Epub 2015 May 1. PubMed 25929664 ↗
  • Simonyan K, Ludlow CL. Abnormal activation of the primary somatosensory cortex in spasmodic dysphonia: an fMRI study. Cereb Cortex. 2010 Nov;20(11):2749-59. doi: 10.1093/cercor/bhq023. Epub 2010 Mar 1. PubMed 20194686 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Dec 2021, 47 months.

Results were first posted in Apr 2025, 3 years 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2017
First posted
Sep 25, 2017
StartActual
Jan 22, 2018
Primary completionActual
Dec 29, 2021
CompletionActual
Oct 11, 2024
Results first posted
Apr 4, 2025
Last update
Dec 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03292458
Lead sponsor
Kristina Simonyan
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Responsible party
Kristina Simonyan (Professor of Otolaryngology - Head & Neck Surgery, Director of Laryngology Research, Massachusetts Eye and Ear Infirmary) — Sponsor-investigator
First posted
Sep 25, 2017
Start date
Jan 22, 2018
Primary completion
Dec 29, 2021
Completion
Oct 11, 2024
Results posted
Apr 4, 2025
Last update
Dec 30, 2025

Study contacts

Kristina Simonyan, MD, PhD
principal investigator · Massachusetts Eye and Ear

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Sodium Oxybate

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