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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
sodium oxybate
DrugOral administration of sodium oxybate (1.5g, 2.0g, 2.5g, 3.0g)
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: Clinical response to sodium oxybate (Lumryz)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of Lumryz
The primary outcome will be the percent change from baseline in LD symptoms 60 min after each dose of drug intake
Time frame
Through study completion, an average of 4 days2
Efficacy of Lumryz
The primary outcome will be the number of patients (N, % of total) with improved voice symptoms from baseline after each dose of the drug.
Time frame
Through study completion, an average of 4 daysSecondary outcomes
1
Duration of treatment efficacy
The secondary outcomes will be the duration (in hours) of Lumryz treatment efficacy
Time frame
Through study completion, an average of 4 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kristina Simonyan
Lead sponsor
Massachusetts Eye and Ear Infirmary
Sponsor institution
Source ClinicalTrials.gov
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