A DOUBLE-BLIND PLACEBO CONTROLLED STUDY OF 1g, 2g, AND 4 g V0251 EFFICACY AND TOLERANCE IN VESTIBULAR NEURITIS - ND

Active, not recruiting

• Conditions: V0251 is a new investigational agent which is being developped for the treatment of symptomatic vertiginous crisis.; MedDRA version: 9.1Level: LLTClassification code 10047339Term: Vertiginous syndromes and other disorders of vestibular system

• Registration Number: EUCTR2007-005054-23-IT
• Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-23
• Last Update Posted: 2012-04-18

Recruitment & Eligibility

• Status: Not 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, peak slow phase velocity during caloric irrigation with 30C warm and 44C hot water less than three degrees per second on the affected side for each irrigation ; with an asymetry between the two sides more than 25 percent according to Jongkees? s formula during the bithermal caloric test which will be performed 3 days after treatment (initiated at inclusion visit), - 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, sexual abstinence or vasectomised partner related to note 3 of the CPMP/ICH/286/95, see appendix 17.5) for at least 2 months before the study and one month after the end of the study, - Patient accepting to participate to the study and able to understand and sign an approved Informed Consent Form, - Patient able to understand the protocol and to come to the control visits, - Patient who, in the judgement of the investigator is likely to be compliant during the study - Registered with a social security or health insurance system
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 - Vestibular dysfunction 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, * Criteria related to treatments - Patient with history of hypersensitivity to ace`tylleucine or excipients, - History of systemic or transtympanic administration of aminoglycosides or any other ototoxic substances, - More than one antivertigo drug oral or intravenous administration before inclusion visit, - Hypnotics, antidepressants, if prescription initiated or modified within the 3 previous months before inclusion visit, * 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 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, - Patient who, in the judgement of the investigator, is not likely to be compliant during the study, - 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