A Multicentre, randomized, double-blind, placebo-controlled, four parallel group study of 1g, 2g and 4g V0251 efficacy and tolerance in vestibular neuritis.
- Conditions
- Health Condition 1: null- Vestibular neuritis (acute unilateral vestibulopathy)
- Registration Number
- CTRI/2009/091/000678
- Lead Sponsor
- A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 120
Will be eligible subjects who meet the following 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 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.
NON INCLUSION CRITERIA
?Criteria related to pathologies
-Chronic 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 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,
- Non allowed treatment (see section 7)
?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 has forfeited his/her freedom by administrative or legal decision, or who is under guardianship.
Exclusion Criteria:
Criteria related to pathologies:
Will not be included subjects who have one of the following criteria:
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method