What side effects are associated with this type of intervention?

Treatments for Voice Tremor that modulate neurotransmitter activity, particularly GABA, such as Sodium Oxybate, can have side effects including nausea, dizziness, headache, and potentially severe effects like respiratory depression and deep sedation. Similar GABA-modulating treatments, like benzodiazepines, may also cause drowsiness, cognitive impairment, and dependency.

What prior FDA approvals exist?

There is no specific mention of FDA-approved drugs for the treatment of Voice Tremor in the provided context. However, Sodium Oxybate, which modulates neurotransmitter activity, particularly GABA, is being studied for its effects on voice symptoms in conditions like spasmodic dysphonia and voice tremor. Other GABA-modulating drugs, such as benzodiazepines like clonazepam, have been used for various movement disorders but are not specifically noted for Voice Tremor in the context provided.

What other types of research exist?

Promising novel alternatives to Sodium Oxybate for voice tremor patients include AIT-082, which has shown efficacy in reducing tremor intensity and duration in preclinical studies, and safinamide, which has demonstrated tremorolytic effects in animal models of parkinsonian tremor. Both of these treatments modulate neurotransmitter activity and could be considered for further investigation in voice tremor management.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Myoclonus episode

Sleep terror

Suicidal ideation

Anxiety

Asthenia

Tremor

Auditory hallucination

Enuresis

Gastrointestinal discomfort

Myalgia

Dizziness

Headache

Nausea

Hot flashes

Catathrenia

Sensation of being "wired"

Dysgeusia

100%

80%

60%

40%

20%

Study treatment Arm

Sodium Oxybate (SXB) Arm

Placebo (PBO) Arm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met

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].