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.
Conditions
Interventions
Trade Name: Timonil retard
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Carbamazepine
CAS Number: 298-46-4
Other descriptive name: CARBAMAZEPINE
Concentration unit: mg milligram(s)
Concentr
Sponsors
University of the University of Munich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the comparison of carbamazepine and placebo is to demonstrate that CBZ is efficacious in reducing the number of vertigo attacks in patients with vestibular paroxysmia measured by a diary.;Secondary Objective: To demonstrate that carbamazepine is efficacious in 1) improving impairment and qualitiy of life (assessed by the Dizziness Handicap Inventory (DHI), the Vestibular Disorders Activities of Daily Living Scale (VDADL) and the EQ-5D-5L) 2) shorten the average duration of the attacks and median severity of the attacks of vertigo 3) shorten the hyperventilation induced vertigo and/or nystagmus 4) reduce days with vertigo To assess the side effects, adverse events, SAEs SUSAR;Primary end point(s): Number of vertigo attacks per month during the 6-week treatment periods;Timepoint(s) of evaluation of this end point: Assessment with a diary during the 6week treatment period and the 6-week placebo period Collection at visit V5 and V9 at the end of the treatment periods | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Days with vertigo during the two treaments periods 2) Change of the Dizziness Handicap Inventory (DHI), the Vestibular Disorders Activities of Daily Living Scale (VDADL) and the EQ-5D-5L), administration evaluated at the start as well as the end of both treatment periods and the last study visit 3) average (per day) duration of the attacks of vertigo and median severity of the attacks of vertigo reported by the patient during both treatment periods 4) change of hyperventilation induced vertigo and/or nystagmus, administration at the start, at the end of both treatment periods and at the end of the study;Timepoint(s) of evaluation of this end point: administration at the start, at the end of both treatment periods and at the end of the study | — |
Countries
Germany
Contacts
Public ContactDSGZ Studienzentrale
Hospital of the University of Munich
Outcome results
None listed