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Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor

NCT03292458 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2025-12-30

Study results available
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Summary

Using a comprehensive approach of clinico-behavioral testing, neuroimaging and pharmacogenetics, the researchers will examine the clinical effects of sodium oxybate and the matched placebo on voice symptoms in spasmodic dysphonia and voice tremor.

Conditions

  • Spasmodic Dysphonia
  • Voice Tremor

Interventions

DRUG

Sodium Oxybate

Alcohol challenge test and oral administration of a single dose of sodium oxybate and the matching placebo.

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • Kristina Simonyan

    lead OTHER

Principal Investigators

  • Kristina Simonyan, MD, PhD · Massachusetts Eye and Ear

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-01-22
Primary Completion
2021-12-29
Completion
2024-10-11
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 NCT03292458 on ClinicalTrials.gov