CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 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/NCT01961297
NCT01961297Phase 2Completed

Voice Tremor in Spasmodic Dysphonia: Central Mechanisms and Treatment Response

Kristina Simonyan·interventional·Posted Oct 11, 2013·Updated Nov 22, 2017

In Brief

A Phase 2 clinical trial evaluating Sodium oxybate for Spasmodic Dysphonia and Voice Tremor. Completed, enrolled 53 participants across 1 site.

Detailed Summary

The proposed research aims to determine brain abnormalities in patients with spasmodic dysphonia (SD) and voice tremor (VT) as the basis for characterization of central mechanisms underlying symptom improvement following the use of sodium oxybate, a novel oral medication for the treatment of ethanol-responsive dystonia. The proposed research is relevant to public health because the elucidation of disorder-specific mechanistic aspects of brain organization in SD vs. SD/VT is ultimately expected to lead to establishment of enhanced criteria for clinical management of these disorders, including differential diagnosis and treatment. Thus, the proposed research is relevant to the part of NIH's mission that pertains to developing fundamental knowledge that will help to reduce the burdens of human disability.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 11, 2013
Enrollment StartJul 1, 2012
Primary CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 12.7 years ago

Interventions

Sodium oxybatedrug

Sodium oxybate