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

Launched by KRISTINA SIMONYAN · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new extended-release form of a medicine called sodium oxybate (brand name Lumryz) to see if it can help improve voice problems in people with spasmodic dysphonia and voice tremor. These conditions cause involuntary spasms or shaking in the voice muscles, making speaking difficult. The study will look at how this medicine affects voice symptoms by combining tests of voice behavior with brain imaging.

People who may join the study are adults aged 21 to 80 who have a diagnosis of alcohol-responsive laryngeal dystonia (a type of spasmodic dysphonia that gets better with alcohol) and who have previously responded well to an immediate-release version of sodium oxybate. Participants must be willing to follow all study procedures and attend all visits. The study is currently not recruiting yet. Those with serious health issues like certain heart, liver, or kidney problems, brain or psychiatric conditions, or who are pregnant, breastfeeding, or have high daytime sleepiness will not be eligible. Participants can expect to take the extended-release medicine and undergo voice testing and brain scans to help researchers understand how well the treatment works.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provision of signed and dated informed consent form
• • 2. Stated willingness to comply with all study procedures and lifestyle considerations (see Lifestyle Considerations below) and availability for the duration of the study
• • 3. Males and females
• • 4. Age 21-80 years
• • 5. Documented diagnosis of alcohol-responsive laryngeal dystonia
• • 6. Documented positive response to immediate-release sodium oxybate (Xyrem) in prior studies
• • 7. Willingness to adhere to the study intervention regimen
• Exclusion Criteria:
• • 1. The incapability of giving informed consent
• • 2. Pregnancy or breastfeeding until a time when they are no longer pregnant or breastfeeding
• • 3. Grade 2 or higher hepatic or renal dysfunction according to the NCI criteria
• • 4. Moderate to severe congestive heart failure
• • 5. Cognitive impairment (MoCA \< 26)
• • 6. Past or present suicidal ideations (according to C-SSRS)
• • 7. Alcoholism or high risk for alcohol use disorder according to the NIAAA definition and DSM-5 criteria
• • 8. Asymptomatic presentation due to botulinum toxin treatment until the time they are fully symptomatic and are at least 3 months after the last injection
• • 9. Increased daytime sleepiness (Epworth Sleepiness Scale (ESS\>10))
• • 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.
• • 11. Past or present history of any psychiatric problems, such as schizophrenia, major and/or bipolar depression, or obsessive-compulsive disorder
• • 12. Current use of medication(s) affecting the central nervous system
• • 13. Past or present history of brain and/or laryngeal surgery
• • 14. 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