Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-80
SponsorKristina Simonyan
About this trial
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.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and lifestyle considerations (see Lifestyle Considerations below) and availability for the duration of the study
Males and females
Age 21-80 years
Disqualifiers
The incapability of giving informed consent
Pregnancy or breastfeeding until a time when they are no longer pregnant or breastfeeding
Grade 2 or higher hepatic or renal dysfunction according to the NCI criteria
Moderate to severe congestive heart failure
Trial design
Treatments tested in this trial
- sodium oxybate
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
Kristina Simonyan
Lead sponsor
Massachusetts Eye and Ear Infirmary
Sponsor institution
Source ClinicalTrials.gov