NCT07041203

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

Central Mechanisms and Treatment Response of Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Kristina Simonyan · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Spasmodic dysphonia (SD), or laryngeal dystonia, is a chronic, debilitating condition that selectively affects speech production due to involuntary spasms in the laryngeal muscles. SD often extends beyond the impairment of vocal communication, causing significant occupational disability and life-long social isolation. Treatment of SD is limited to injections of botulinum toxin into the vocal cords, however, it is often only partially effective and can have side effects. More than half of the people with SD have some relief from drinking alcohol. The previous studies showed that immediate-release sodium oxybate (an oral drug that acts similarly to alcohol) significantly relieves voice symptoms in patients with alcohol-responsive SD. In this study, we will examine the efficacy and safety of extended-release sodium oxybate formulation (Lumryz) as a longer-acting oral agent for the treatment of patients with alcohol-responsive SD.

Conditions

• Spasmodic Dysphonia
• Laryngeal Dystonia
• Voice Tremor

Interventions

Type	Name	Description
DRUG	sodium oxybate	Oral administration of sodium oxybate (1.5g, 2.0g, 2.5g, 3.0g)

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2025-06-27
• Last updated: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study