E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
V0251 is a new investigational agent which is being developped for the treatment of symptomatic vertiginous crisis. |
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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 | 10047339 |
E.1.2 | Term | Vertiginous syndromes and other disorders of vestibular system |
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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 on central vestibular compensation of 3 doses versus placebo of L-acetylleucine within 4 days of intravenous administration in patient hospitalised for acute vestibular neuritis |
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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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
PEAK SLOW PHASE EYE VELOCITY OF HORIZONTAL SPONTANEOUS NYSTAGMUS ON DAY 4 |
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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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 38 |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |