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 range
21 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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