Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor
A legfontosabb adatok
- Hol
- Boston (Egyesült Államok)A helyszín megnézése
- Fázis
- 1. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 21 és 80 év között vagy?
Forrás: NCT07041203: ki vehet részt
Helyszínek itt: Egyesült Államok
- Massachusetts Eye and EarBoston, Egyesült ÁllamokContact: Kristina Simonyan, MD, PhD, DrMedNo longer taking part
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Kristina Simonyan
- Azonosító
- NCT07041203
- A regiszteradat frissítve
- 2026. április 28.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Central Mechanisms and Treatment Response of Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor
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.
Bevonási feltételek: 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; Documented diagnosis of alcohol-responsive laryngeal dystonia; Documented positive response to immediate-release sodium oxybate (Xyrem) in prior studies; Willingness to adhere to the study intervention regimen.
Kizáró feltételek: Current use of medication(s) affecting the central nervous system; Moderate to severe congestive heart failure; Cognitive impairment (MoCA < 26); Alcoholism or high risk for alcohol use disorder according to the NIAAA definition and DSM-5 criteria; 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; Past or present history of any psychiatric problems, such as schizophrenia, major and/or bipolar depression, or obsessive-compulsive disorder; Past or present history of brain and/or laryngeal surgery; 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/or cannot be removed for the purpose of MRI study participation; 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; Past or present suicidal ideations (according to C-SSRS); Asymptomatic presentation due to botulinum toxin treatment until the time they are fully symptomatic and are at least 3 months after the last injection; Increased daytime sleepiness (Epworth Sleepiness Scale (ESS>10)).