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. |
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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 | 10047340 |
E.1.2 | Term | Vertigo |
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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 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 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 - To assess a dose-effect relationship |
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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, *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) for at least 2 months before the study and one month after the end of the study, |
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E.4 | Principal exclusion criteria |
*Criteria related to pathologies : - Chronic vestibular dysfunction before the acute onset of symptoms, - Acute hearing loss during, or after the onset of vertigo - Acute, unilateral (same side as the affected ear) tinnitus during, or after the onset of vertigo, - Central ocular motor dysfunction - Central vestibular dysfunction - Symptoms of cerebellar dysfunction - Symptoms of central neurological disorder - History or symptoms of vestibular migraine -Recent history of ear and/or head trauma, -Tympanic membrane perforation -Chronic otitis,
*If the Bithermal Caloric Test cannot be performed on D1, due to the state of the patient (nausea, vomiting). In consequence this test will be performed as soon as the patient is able to support, i.e. on D3. *If 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
*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 oral or intravenous antivertigo drug administrations before inclusion visit, - Patient taking non allowed medications
*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 efficient contraception, or planning to become pregnant during the study period or within one month after the end of the study, - 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. |
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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 D4 |
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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 | 25 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 19 |
E.8.9.2 | In all countries concerned by the trial days | 0 |