Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor

Starting soon · Phase 1

Conditions studied: Spasmodic Dysphonia, Laryngeal Dystonia, Voice Tremor

In brief

Using a comprehensive approach of clinico-behavioral testing and neuroimaging, the researchers will examine the clinical effects of the extended-release formulation of sodium oxybate on voice symptoms in spasmodic dysphonia in an open-label, proof-of-concept, dose-finding study.

Key facts

Study ID

NCT07041203

Run by

Kristina Simonyan

People needed

8

Starts

2026-10-01

Expected to finish

2027-09-30

Last updated by the study team

2026-04-28

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and lifestyle considerations (see Lifestyle Considerations below) and availability for the duration of the study
• Males and females
• Age 21-80 years
• Documented diagnosis of alcohol-responsive laryngeal dystonia
• Documented positive response to immediate-release sodium oxybate (Xyrem) in prior studies
• Willingness to adhere to the study intervention regimen

You may not qualify if…

• The incapability of giving informed consent
• Pregnancy or breastfeeding until a time when they are no longer pregnant or breastfeeding
• Grade 2 or higher hepatic or renal dysfunction according to the NCI criteria
• Moderate to severe congestive heart failure
• Cognitive impairment (MoCA < 26)
• Past or present suicidal ideations (according to C-SSRS)
• Alcoholism or high risk for alcohol use disorder according to the NIAAA definition and DSM-5 criteria
• Asymptomatic presentation due to botulinum toxin treatment until the time they are fully symptomatic and are at least 3 months after the last injection
• Increased daytime sleepiness (Epworth Sleepiness Scale (ESS>10))
• Past or present history of any neurological disorders (except for LD and co-occurring voice tremor), such as stroke, movement disorders, brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug dependence.
• Past or present history of any psychiatric problems, such as schizophrenia, major and/or bipolar depression, or obsessive-compulsive disorder
• Current use of medication(s) affecting the central nervous system
• Past or present history of brain and/or laryngeal surgery
• Presence of certain 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

Where it is running

• Massachusetts Eye and Ear — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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