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

NCT07041203 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

  • Spasmodic Dysphonia
  • Laryngeal Dystonia
  • Voice Tremor

Interventions

DRUG

sodium oxybate

Oral administration of sodium oxybate (1.5g, 2.0g, 2.5g, 3.0g)

Sponsors & Collaborators

  • Kristina Simonyan

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07041203 on ClinicalTrials.gov