[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596111":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":22,"locations":28,"responsibleParty":47,"collaborators":21,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":21,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":21,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":21,"overallStatus":72,"whyStopped":21,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Massachusetts Eye and Ear Infirmary","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Clinical response to sodium oxybate (Lumryz)","EXPERIMENTAL","Oral administration of sodium oxybate (1.5g, 2.0g, 2.5g, 3.0g)",[13],"Drug: sodium oxybate",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","sodium oxybate",[9],[20],"Lumryz",null,[23],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},"Kristina Simonyan, MD, PhD, DrMed","CONTACT","6175736025","kristina_simonyan@meei.harvard.edu",[29],{"facility":30,"status":21,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Massachusetts Eye and Ear","Boston","Massachusetts","02114","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-71.05977,42.35843,{"lat":40,"lon":39},[43,45],{"name":24,"role":25,"phone":44,"phoneExt":21,"email":27},"6175736016",{"name":24,"role":46,"phone":21,"phoneExt":21,"email":21},"PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"SPONSOR_INVESTIGATOR","Kristina Simonyan","Professor of Otolaryngology-Head and Neck Surgery","100596111","phase-1-extended-release-sodium-oxybate-lumryz-in-spasmodic-dysphonia-and-voice-tremor-100596111",false,"NCT07041203","Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor","Central Mechanisms and Treatment Response of Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and lifestyle considerations (see Lifestyle Considerations below) and availability for the duration of the study\n3. Males and females\n4. Age 21-80 years\n5. Documented diagnosis of alcohol-responsive laryngeal dystonia\n6. Documented positive response to immediate-release sodium oxybate (Xyrem) in prior studies\n7. Willingness to adhere to the study intervention regimen\n\nExclusion Criteria:\n\n1. The incapability of giving informed consent\n2. Pregnancy or breastfeeding until a time when they are no longer pregnant or breastfeeding\n3. Grade 2 or higher hepatic or renal dysfunction according to the NCI criteria\n4. Moderate to severe congestive heart failure\n5. Cognitive impairment (MoCA \\\u003C 26)\n6. Past or present suicidal ideations (according to C-SSRS)\n7. Alcoholism or high risk for alcohol use disorder according to the NIAAA definition and DSM-5 criteria\n8. Asymptomatic presentation due to botulinum toxin treatment until the time they are fully symptomatic and are at least 3 months after the last injection\n9. Increased daytime sleepiness (Epworth Sleepiness Scale (ESS\\>10))\n10. Past or present history of any neurological disorders (except for LD and co-occurring voice tremor), such as stroke, movement disorders, brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug dependence.\n11. Past or present history of any psychiatric problems, such as schizophrenia, major and\u002For bipolar depression, or obsessive-compulsive disorder\n12. Current use of medication(s) affecting the central nervous system\n13. Past or present history of brain and\u002For laryngeal surgery\n14. Presence of certain tattoos, ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve, etc.) that are not MRI comparable and\u002For cannot be removed for the purpose of MRI study participation","ALL","21 Years","80 Years",{"count":62,"type":63},8,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","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.",[69,70,71],"Spasmodic Dysphonia","Laryngeal Dystonia","Voice Tremor","NOT_YET_RECRUITING","2026-04-25",{"date":75,"type":76},"2026-04-28","ACTUAL",{"date":78,"type":63},"2026-10-01",{"date":80,"type":63},"2027-09-30",{"name":49,"class":6},1]