A double-blind placebo controlled study of 1g, 2g and 4g V0251 efficacy and tolerance in vestibular neuritis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

- patient aged above 18 years,
- patient admitted to the hospital for vertigo related to acute vestibular neuritis,
- vestibular neuritis (acute unilateral vestibulopathy) defined as :
* acute or subacute onset of severe, prolonged rotatory vertigo, nausea and postural imbalance that began less than 48h before the inclusion visit,
*horizontal spontaneous nystagmus with a rotational component beating toward the unaffected ear (fast phase), without evidence of central vestibular lesion,
*pathological Head ImpulseTest (Halmagyi-Curthoys) toward the affected side-- Negative pregnancy test at inclusion for woman of child bearing potential and using an efficient contraceptive (implants, injectables, combined oral contraceptives, some intra-uterine devices or vasectomised partner) for at least 2 months before the study and one month after the end of the study,
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

*Criteria related to pathologies :
- Chronic vestibular dysfunction before the acute onset of symptoms,
- Acute hearing loss during, or after the onset of vertigo
- Acute, unilateral (same side as the affected ear) tinnitus during, or after the onset of vertigo,
- Central ocular motor dysfunction
- Central vestibular dysfunction
- Symptoms of cerebellar dysfunction
- Symptoms of central neurological disorder
- History or symptoms of vestibular migraine
-Recent history of ear and/or head trauma,
-Tympanic membrane perforation
-Chronic otitis,

*If the Bithermal Caloric Test cannot be performed on D1, due to the state of the patient (nausea, vomiting). In consequence this test will be performed as soon as the patient is able to support, i.e. on D3.
*If no deficit on Bithermal Caloric Test performed at D3. Caloric hypoexitability of the affected ear defined by a Nystagmus beating toward the affected side of more than three degrees per seconde after hot (44°c) stimulation of the affected ear

*Criteria related to treatments:
- Patient with history of hypersensitivity to acetylleucine or excipients,
- History of systemic or transtympanic administration of aminoglycosides or any other ototoxic substances,
- More than two oral or intravenous antivertigo drug administrations before inclusion visit,
- Patient taking non allowed medications

*Criteria related to the population
- Medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, puts them ‘at risk’ or is likely to modify their handling of the study drug,
- Female who is pregnant or breast feeding or not using efficient contraception, or planning to become pregnant during the study period or within one month after the end of the study,
- Participation to an other clinical trial in the previous month or during the study,
- Patient who, is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent,
- Patient who has forfeited his/her freedom by administrative or legal decision, or who is under guardianship.

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

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