Prophylactic treatment of vestibular paroxysmia with carbamazepine: a prospective, randomized, placebo-controlled, cross-over, multi-center trial - VesPa

niversity of the University of Munich0 个研究点目标入组 153 人开始时间: 2015年12月9日最近更新: 2020年8月10日

适应症

试验速览

暂无简介。

•- Written Informed Consent
•- Over 18 years of age
•- at least 5 attacks in the three months prior to inclusion
•- attacks last less than 5 minutes
•- course of attacks is stereotypical of the individual patient
•- spontaneous occurence or provocation due to certain head movements
•- The symptoms cannot be explained by another disease, in particular Menière’s disease, vestibular migraine, BPPV or perilymph fistula.
•- The ability to follow study instructions and likely to attend and complete all visits
•- Female subjects with childbearing potential and fertile men are eligible if they use a medically accepted highly effective contraceptive method.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 53

•- Other vestibular disorders such as Menière’s disease, BPPV, vestibular migraine or perilymph fistula at the time of inclusion
•- Paroxysmal brainstem attacks after stroke or in multiple sclerosis
•- Episodic ataxia
•- Absence seizures or types of epilepsy, which include absence seizures
•- Intake of other antiepileptic drugs
•- Severe hepatic, cardiac or renal failure
•- Known intolerance to carbamazepine
•- Known intolerance to structurally related substances, for example tricyclic antidepressants
•- Known damage of the bone marrow or aute and/or previous severe haematological diseases
•- Atrioventricular block
•- Active Pregnancy or breast-feeding
•- Known hepatic porphyria
•- Required therapy with MAO-Inhibitors, voriconazol or stiripentol
•- Hypo- or hypernatraemia
•- Known Myotonic dystrophia
•- Known Alcoholabuse
•- Life expectancy under 12 months
•- Participation in another study with an investigational drug or device within the last 30 days before participating of the study

发起方

niversity of the University of Munich