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Central Nervous System Depressant

Sodium Oxybate for Voice Disorders

Phase 2 & 3
Waitlist Available
Led By Kristina Simonyan, MD, PhD
Research Sponsored by Kristina Simonyan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age from 21 to 80 years
Native English speakers
Must not have
Patients with a past or present history of 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
Patients who are not symptomatic due to treatment with botulinum toxin injections into the laryngeal muscles
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This trial tests if sodium oxybate, an oral medication, can improve voice symptoms in patients with spasmodic dysphonia and voice tremor by affecting brain mechanisms. Sodium oxybate has shown significant improvement in voice symptoms for patients with spasmodic dysphonia and voice tremor in previous studies.

Who is the study for?
This trial is for adults aged 21-80 with spasmodic dysphonia or voice tremor, who are right-handed native English speakers. It's not for those with other laryngeal issues, recent botulinum toxin treatments, neurological/psychiatric disorders, severe liver/kidney disease, heart failure, CNS-affecting drugs (except sodium oxybate), or a history of certain surgeries.
What is being tested?
Researchers are testing the effects of Sodium Oxybate on voice symptoms in patients with spasmodic dysphonia and voice tremor using clinical assessments, brain imaging and genetic testing to compare it against a placebo.
What are the potential side effects?
Sodium Oxybate may cause side effects such as dizziness, nausea, sleepiness during daytime hours. Since it affects the central nervous system, there might be changes in alertness and mood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 80 years old.
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I am a native English speaker.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have no history of major neurological disorders or tremors affecting parts of my body other than my voice box.
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I have not had symptoms from botulinum toxin injections in my throat muscles.
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I have had surgery on my brain or voice box.
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I am unable to understand and give consent for treatment.
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I have or had moderate to severe heart failure.
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I have had serious liver or kidney problems in the past or now.
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I have had issues with my voice box, including paralysis, weakness, cancer, or long-term inflammation.
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I am taking medication that affects my brain, excluding sodium oxybate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sodium oxybate
Secondary study objectives
Attenuation of brain functional abnormalities following sodium oxybate vs. placebo

Side effects data

From 2022 Phase 4 trial • 24 Patients • NCT04006925
17%
Brain fog
17%
Anorexia
17%
Increased sweating
8%
Myoclonus episode
8%
Sleep terror
8%
Suicidal ideation
8%
Anxiety
8%
Asthenia
8%
Tremor
8%
Auditory hallucination
8%
Enuresis
8%
Gastrointestinal discomfort
8%
Myalgia
8%
Dizziness
8%
Headache
8%
Nausea
8%
Hot flashes
8%
Catathrenia
8%
Sensation of being "wired"
8%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sodium Oxybate (SXB) Arm
Placebo (PBO) Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: Primary markers of clinical responseExperimental Treatment1 Intervention
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.
Group II: Clinical response to sodium oxybateExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium Oxybate
2001
Completed Phase 4
~610

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Voice Tremor treatments often target neurotransmitter activity to stabilize vocal cord function. Sodium Oxybate, for instance, modulates GABA activity, which helps to reduce tremor by enhancing inhibitory neurotransmission and stabilizing neural activity. This is crucial for Voice Tremor patients as it can lead to significant improvements in voice control and quality. Other treatments may include beta-blockers, which reduce tremor by blocking adrenaline receptors, and anticonvulsants, which stabilize nerve cell activity. These mechanisms are vital as they directly address the neurological disruptions causing the tremor, thereby improving patients' vocal performance and quality of life.
Deprenyl's effect at slowing progression of parkinsonian disability: the DATATOP study. The Parkinson Study Group.Appraisal of anti-Parkinson activity of rhinacanthin-C in haloperidol-induced parkinsonism in mice: A mechanistic approach.[A study of combination treatment with nacom (levodopa + carbodope) and citicoline in the model of Parkinson disease in rats].

Find a Location

Who is running the clinical trial?

Kristina SimonyanLead Sponsor
3 Previous Clinical Trials
604 Total Patients Enrolled
2 Trials studying Voice Tremor
463 Patients Enrolled for Voice Tremor
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
348 Previous Clinical Trials
180,597 Total Patients Enrolled
3 Trials studying Voice Tremor
480 Patients Enrolled for Voice Tremor
Kristina Simonyan, MD, PhDPrincipal Investigator - Massachusetts Eye and Ear
Massachusetts Eye and Ear Infirmary
8 Previous Clinical Trials
2,094 Total Patients Enrolled
2 Trials studying Voice Tremor
463 Patients Enrolled for Voice Tremor
~18 spots leftby Sep 2025
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