E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
V0251 is a new investigational antivertiginous agent which is being developed for the treatment of symptomatic vertiginous crisis. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047340 |
E.1.2 | Term | Vertigo |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine efficacy of 3 doses versus placebo of L-acetylleucine within 4 days of intravenous administration in patient hospitalised for vestibular neuritis. |
|
E.2.2 | Secondary objectives of the trial |
- 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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Peak slow phase eye velocity of horizontal spontaneous nystagmus on D4. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 17 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 17 |