Double-Blind, Placebo-Controlled, Single-Dose Trial of 1-Octanol in Essential Tremor
1-Octanol
Enfermedades del Sistema Nervioso Central+4
+ Trastornos del Movimiento
+ Enfermedades del sistema nervioso
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de enero de 2000
Fecha en la que se inscribió al primer participante.Essential tremor (ET) is the most common movement disorder; however, there is currently no satisfactory drug treatment. The neural mechanisms underlying ET remain unknown. One of the prevalent hypotheses is that ET is a result of a defective mechanism that normally dampens the natural oscillations of inferior olive (IO) neurons whose intrinsic oscillatory activity is attributed to the presence of low threshold calcium channels (LTCC). 1-Octanol is known to inhibit LTCC of olivary neurons and was found to reduce the tremor induced in rats with harmaline, an alkaloid known to hyperpolarize IO neurons increasing their tendency to fire rhythmically at rest. The aim of this study is to assess the effects of 1-octanol on ET in humans. This study is designed as a double-blind, placebo-controlled, single-dose trial in untreated patients with ET. Electromyography (EMG) and acclerometry are used to assess tremor before and after 1-octanol administration. The accepted daily intake (ADI) of 1-octanol (1 mg/kg/d) as a food additive will be given as a single dose. Toxicity from octanol will be monitored clinically and by liver function and electrolyte measurements.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 12 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Patients with essential tremor affecting the upper limbs who are 21 years of age or older. Patients who are not taking medications for essential tremor or any other medical condition for at least 2 weeks. Patients who have not consumed alcohol or cold medications containing alcohol for at least 24 hours prior to the day of the study. Women must not be pregnant or lactating. Women of childbearing age must use birth control while participating in this study. Patients must not have any neurological disease other than tremor (e.g., Parkinson's disease). Patients must not have evidence of thyroid, liver, kidney or chronic lung disease.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, United StatesAbrir National Institute of Neurological Disorders and Stroke (NINDS) en Google Maps