Treatment of vestibular paroxysmia with carbamazepine
- Conditions
- The main symptoms of vestibular paroxysmia are brief attacks of rotatory or postural vertigo lasting seconds to a few minutes with or without ear symptoms (tinnitus and hypoacusis). As in trigeminal neuralgia or hemifacial spasm, it is assumed that a neurovascular cross-compression of the eighth cranial nerve is the cause of the attacks.Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-000388-15-DE
- Lead Sponsor
- niversity of the University of Munich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 153
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method