V0251 is a new investigational antivertiginous agent which is being developed for the treatment of symptomatic vertiginous crisis. MedDRA version: 9.1 Level: LLT Classification code 10047340 Term: Vertigo
Conditions
Interventions
Product Name: acetyl-L-leucine
Product Code: V0251
Pharmaceutical Form: Solution for injection
INN or Proposed INN: acetyl-L-leucine
CAS Number: 1188-21-2
Current Sponsor code: V0251
Other descriptive
Sponsors
PIERRE FABRE MEDICAMENT - IRPF
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patients aged above 18 years, - patients admitted to the hospital for vertigo related to 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 30°C warm and 44°C 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 2 days after treatment (initiated at inclusion visit), - negative urine pregnancy test at inclusion for woman of child bearing potential and using an efficient contraceptive (oral contraceptive, intrauterine device, tubal ligature) 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
Exclusion criteria: *Criteria related to pathologies: - vestibular dysfonction before the acute onset of symptoms, - cochlear symptoms such as tinnitus or 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, - 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 susbtances, - more than one antivertigo drug intravenous administration before inclusion visit, - antivertigo drug oral route administration, - hypnotics, antidepressants, if prescription initiated or modified within the 3 previous months before the inclusion visit. *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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Peak slow phase eye velocity of horizontal spontaneous nystagmus on D4.;Secondary Objective: - To determine treatment duration - To assess a dose-effect relationship - To determine tolerance of 3 doses of L-acetylleucine within 4 days of intravenous administration in patient hospitalised for vestibular neuritis - To determine optimal dose (efficacy and tolerance) of L-acetylleucine within 4 days of intravenous administration in patient hospitalised for vestibular neuritis - To evaluate the primary criteria and the endpoint choices;Main Objective: To determine efficacy of 3 doses versus placebo of L-acetylleucine within 4 days of intravenous administration in patient hospitalised for vestibular neuritis. | — |
Countries
Belgium, Czech Republic, France, Germany, Italy, Spain
Outcome results
None listed