Double-Blind, Placebo-Controlled, Single-Dose Trial of 1-Octanol in Essential Tremor
1-Octanol
Maladies du système nerveux central+6
+ Troubles du mouvement
+ Maladies du système nerveux
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 2000
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.12 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, United StatesOuvrir National Institute of Neurological Disorders and Stroke (NINDS) dans Google Maps