Central Mechanisms and Treatment Response of Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor
Kristina Simonyan
Summary
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.
Description
Spasmodic dysphonia (SD), or laryngeal dystonia, is a chronic, debilitating condition that selectively affects speech production due to involuntary spasms in the laryngeal muscles. SD often extends beyond the impairment of vocal communication, causing significant occupational disability and life-long social isolation. Treatment of SD is limited to injections of botulinum toxin into the vocal cords, however, it is often only partially effective and can have side effects. More than half of the people with SD have some relief from drinking alcohol. The previous studies showed that immediate-relea…
Eligibility
- Age range
- 21–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and lifestyle considerations (see Lifestyle Considerations below) and availability for the duration of the study 3. Males and females 4. Age 21-80 years 5. Documented diagnosis of alcohol-responsive laryngeal dystonia 6. Documented positive response to immediate-release sodium oxybate (Xyrem) in prior studies 7. Willingness to adhere to the study intervention regimen Exclusion Criteria: 1. The incapability of giving informed consent 2. Pregnancy or breastfeedi…
Interventions
- Drugsodium oxybate
Oral administration of sodium oxybate (1.5g, 2.0g, 2.5g, 3.0g)
Location
- Massachusetts Eye and EarBoston, Massachusetts