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

This study is looking at how well an extended-release medication called Lumryz (sodium oxybate) works for people with spasmodic dysphonia (laryngeal dystonia) and voice tremor. Spasmodic dysphonia causes involuntary muscle spasms in the voice box, making speech difficult. Current treatments, like Botox injections, often don't fully help and can have side effects. Since many people with spasmodic dysphonia find relief from alcohol, and immediate-release sodium oxybate works similarly to alcohol, researchers want to see if Lumryz, a longer-acting form, can help. They will be giving different doses of Lumryz (1.5g, 2.0g, 2.5g, 3.0g) by mouth. The study aims to see how effective Lumryz is in improving voice symptoms over an average of 4 days. You may be able to join if you are between 21 and 80 years old, male or female, and have been diagnosed with alcohol-responsive laryngeal dystonia. The study's current status is unclear, and it plans to enroll 8 participants.

Study design
This is an open-label, proof-of-concept, dose-finding study, meaning both you and the researchers will know which treatment you are receiving. It plans to enroll 8 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of the study is to measure the effectiveness of Lumryz through study completion, which is an average of 4 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07041203

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

Not Yet Recruiting
PHASE1Ages 21–80InterventionalTreatment
Kristina Simonyan
~8 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:sodium oxybate

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of Lumryz
Measured over Through study completion, an average of 4 days
+1 more outcome measured
Spasmodic Dysphonia
Laryngeal Dystonia
Voice Tremor
1 sites across 1 states
Massachusetts1
Kristina Simonyan, MD, PhD, DrMed
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  • Efficacy of LumryzThrough study completion, an average of 4 days

    The primary outcome will be the percent change from baseline in LD symptoms 60 min after each dose of drug intake

  • Efficacy of LumryzThrough study completion, an average of 4 days

    The primary outcome will be the number of patients (N, % of total) with improved voice symptoms from baseline after each dose of the drug.