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

- patients 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 related to note 3 of the CPMP/ICH/286/95) 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 dysfonction before the acute onset of symptoms,
- Acute, unilateral (same side as the affected ear) tinnitus during, or after the onset of vertigo,
- Acute hearing loss during, or after the onset of vertigo,
- Central ocular motor dysfunction
- Central vestibular dysfunction
- Symptoms of cerebellar disorder
- Symptoms of central neurological disorder
- History or symptoms of vestibular migraine
- Recent history of ear and/or head trauma,
- Tympanic membrane perforation
- Chronic otitis,
- No deficit on Bitehrmal Caloric Test performed at D3

* 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 antivertigo drug oral or intravenous administration before inclusion visit,
- Patient taking non allowed medications (see section 7 of the protocol)

*Criteria related to the population:
- medical history of major medical, psychiatric illness or surgery which, in 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 contraception, or planning to become pregnant,
- 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.

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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