CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 117 enrolled
Drug / intervention
Sodium Oxybatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03292458
NCT03292458Phase 3Completed
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Central Mechanisms and Treatment Response of Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor

Kristina Simonyan·interventional·Posted Sep 25, 2017·Updated Dec 30, 2025

In Brief

A Phase 3 clinical trial evaluating Sodium Oxybate for Spasmodic Dysphonia and Voice Tremor. Completed, enrolled 117 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpasmodic Dysphonia, Voice Tremor
CountriesUnited States
CollaboratorsNational Institute on Deafness and Other Communication Disorders (NIDCD)

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 25, 2017
Enrollment StartJan 22, 2018
Primary CompletionDec 29, 2021
Study CompletionOct 11, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.8 years ago

Interventions

Sodium Oxybatedrug

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