Sodium Oxybate for Voice Disorders

Palo Alto (17 mi)

Overseen byKristina Simonyan, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Kristina Simonyan

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am between 21 and 80 years old.

I am a native English speaker.

Exclusion Criteria

I have no history of major neurological disorders or tremors affecting parts of my body other than my voice box.

I have not had symptoms from botulinum toxin injections in my throat muscles.

I have had surgery on my brain or voice box.

I am unable to understand and give consent for treatment.

I have or had moderate to severe heart failure.

I have had serious liver or kidney problems in the past or now.

I have had issues with my voice box, including paralysis, weakness, cancer, or long-term inflammation.

I am taking medication that affects my brain, excluding sodium oxybate.

Treatment Details

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.

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.