Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor (NCT07041203) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor
United States8 participantsStarted 2026-10-01
Plain-language summary
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.
Who can participate
Age range21 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Efficacy of Lumryz
Timeframe: Through study completion, an average of 4 days
2
Efficacy of Lumryz
Timeframe: Through study completion, an average of 4 days
✕. Asymptomatic presentation due to botulinum toxin treatment until the time they are fully symptomatic and are at least 3 months after the last injection