E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
V0251 is a new antivertiginous agent which is being developed for the treatment of symptomatic vertiginous crisis. |
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E.1.1.1 | Medical condition in easily understood language |
Symptomatic vertiginous crisis (Acute vertigo) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10047340 |
E.1.2 | Term | Vertigo |
E.1.2 | System Organ Class | 10013993 - Ear and labyrinth disorders |
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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 |
The primary objective of the study is to determine the efficacy of one single intravenous injection of 4g of V0251 on vertigo symptoms relief in patient presenting with an attack of acute vertigo from vestibular origin. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to determine the tolerance of 4g of V0251 administered by intravenous route in a single injection. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age 18 to 70 years, included
- Acute vertigo attack due to vestibular disorder that began within 48 hours before the inclusion
- Vertigo sensation lasting more than 20 min
- At least one vertigo symptom of strong intensity (≥3 on the VAS ranging 0-4) on the intensity vertigo scale (see section 17.4 for details) at the moment of the inclusion
- For woman of child bearing potential: negative urine or serum pregnancy test at inclusion and using an efficient contraceptive (surgical or hormonal birth control or intra-uterine device) for at least 2 months before the study and one month after the end of the study, in order to avoid pregnancy while being exposed to the study treatment
- Able to understand the protocol and having signed the written Informed Consent Form. In case of intense vertigo, the informed consent may be signed by a third party (a trustworthy person except an investigator’s team representative or a sponsor representative) after oral consent of the patient, the Informed Consent Form then being signed by the patient before the end of the study.
- Likely to be compliant during the study, in the judgement of the investigator
- Affiliated to the social security system, or is a beneficiary, if applicable in national regulation
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E.4 | Principal exclusion criteria |
Relating to pathologies:
- Signs of brain, brainstem and/or cerebellar dysfunction (e.g. perioral hypoesthesia, facial paresis/palsy, dysphagia, dysarthria, limb paresis and/or hypoesthesia, coordination deficit, confusion/loss of consciousness)
- Concomitant central neurological disorder that may involve vertigo or dizziness (e.g. multiple sclerosis, epilepsy, Parkinson’s disease, Arnold-Chiari’s disease, Wallenberg’s disease)
- Psychogenic vertigo (e.g. vertigo associated with an evident psychiatric disease, postural phobic vertigo, vertigo induced by a conflict or a stress situation, simulation)
- Patient with history of hypersensitivity to acetylleucine or excipients
- Narrow angle glaucoma
- Moderate to severe prostatic hypertrophy or bladder neck obstruction
- Any medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, could jeopardize his / her health.
Relating to treatments:
- Use of ototoxic drugs causing vertigo or dizziness (gentamicin, streptomycin, quinine, mefloquine, methotrexate) within the last month
- Use of acetylleucine within the last 3 months
- Use of the following medications from the onset of symptoms, except if the dosage had been stable for at least 3 months:
- Antihistamines: diphenhydramine, cyclizine, dimenhydrinate, meclozine, hydroxyzine, promethazine
- Calcium antagonists: cinnarizine, flunarizine
- Central antidopaminergics : phenothiazines, thioxanthenes, butyrophenones, benzamides, diazepines, oxazepines, aripiprazole, pimozide, risperidone
- Peripheral antidopaminergics: metoclopramide, alizapride
- Histaminergics: betahistine
- Anticholinergics: scopolamine (hyoscine), homatropine
- GABA agonists: gabapentin, pregabalin
- Ondansetron
- Piribedil, piracetam, trimetazidine, ginkgo biloba
- Acetazolamide
- Oral steroids
- Use of antiepileptic drugs (except GABA agonists if the dosage had been stable for at least 3 months)
Relating to the population:
- Is a family member or work associate (secretary, nurse, technician,…) of the Investigator
- Is pregnant or in post-partum period or a nursing mother
- Has received treatment with known persistent effects or undergone investigation liable to interfere with the present clinical trial
- Mentally unable to understand the nature, objectives and possible consequences of the trial; or refusing its constraints
- Has forfeited his / her freedom by administrative or legal award or is under guardianship
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
-VSM
- Mean Concomitant Symptom Score (CSSM) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.4 | Safety | Yes |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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Last visit of the last patient |
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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 | 9 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |