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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will use a mix of medical tests, brain scans, and genetic information to study the effects of a drug on people with spasmodic dysphonia (trouble speaking) or voice tremor.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sodium oxybate

Secondary outcome measures

Attenuation of brain functional abnormalities following sodium oxybate vs. placebo

Side effects data

From 2022 Phase 4 trial • 24 Patients • NCT04006925

17%

Increased sweating

17%

Anorexia

17%

Brain fog

Anxiety

Nausea

Sensation of being "wired"

Gastrointestinal discomfort

Dysgeusia

Sleep terror

Suicidal ideation

Asthenia

Auditory hallucination

Enuresis

Headache

Hot flashes

Myalgia

Myoclonus episode

Dizziness

Tremor

Catathrenia

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met

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

328 Previous Clinical Trials

178,156 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project only enrolling people who are under the age of 80?

"In order for an individual to be applicable to this study, they must between the ages of 21 and 80. If someone is outside of that age range, there are 10 other trials for those under 18 and 87 for seniors above 65 years old."

Answered by AI

What are the primary health concerns that Sodium Oxybate is used to address?

"Ethylene glycol is most commonly treated with Sodium Oxybate. However, Sodium Oxybate can also be used to disinfect the skin, fight bacterial infections, and other conditions."

Answered by AI

Could you explain the screening process for this clinical trial?

"The trial's ideal participants are those between 21 and 80 years old who have dysphonia. Furthermore, it is crucial that potential patients also meet the following requirements: a documented adductor or abductor form of disorder with or without positive effects of alcohol on their voice symptoms; be in good health with no history laryngeal, neurological, or psychiatric problems; be a native English speaker; and be right-handed (based on Edinburgh Handedness Inventory)."

Answered by AI