EFFECT OF V0251 IN ACUTE VERTIGO. A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED STUDY.

• Register: EUCTR
• Last refreshed on: 17 March 2014
• Main ID: EUCTR2011-003412-23-DE
• Date of registration: 29/12/2011
• Prospective Registration: Yes
• Primary sponsor: Pierre Fabre Médicament - IRPF
• Public title: EFFECT OF V0251 IN ACUTE VERTIGO. A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED STUDY.
• Scientific title: EFFECT OF V0251 IN ACUTE VERTIGO. A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED STUDY.
• Date of first enrolment: 06/06/2012
• Target sample size: 132
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003412-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Czech Republic, Germany, Hungary, Spain

Contacts

• Name: Eric Garrigue
• Affiliation: Pierre Fabre Médicament - IRPF

• Name: Eric Garrigue
• Affiliation: Pierre Fabre Médicament - IRPF

Key inclusion & exclusion criteria

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

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 119
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

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 by oral route within the last 2 weeks
- Use of Acetylleucine by IV route within the last 6 hours prior to baseline evaluations
- Use of the following medications within the last 12 hours prior to baseline evaluations, 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
- Use of steroids from the onset of symptoms, except if the dosage had been stable for at least 3 months
- Use of antiepileptic drugs other than gabapentin and pregabalin

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

V0251 is a new antivertiginous agent which is being developed for the treatment of symptomatic vertiginous crisis.
MedDRA version: 14.1 Level: PT Classification code 10047340 Term: Vertigo System Organ Class: 10013993 - Ear and labyrinth disorders

Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

Intervention(s)

Product Name: N-acetyl-L-leucine
Product Code: V0251
Pharmaceutical Form: Solution for injection
CAS Number: 1188-21-2
Current Sponsor code: V0251
Other descriptive name: N-acetyl-L-leucine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Primary end point(s): Mean Vertigo Score (VSM)

Timepoint(s) of evaluation of this end point: 30 min

Secondary Objective: The secondary objective is to determine the tolerance of 4g of V0251 administered by intravenous route in a single injection.

Main Objective: 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.

Secondary Outcome(s)

Secondary end point(s): - VSM
- Mean Concomitant Symptom Score (CSSM)
- Overall Efficacy rated by the patient and the investigator using a graded 5-point verbal rating scale

Timepoint(s) of evaluation of this end point: 30 minutes 2 and 4 hours

Secondary ID(s)

2011-003412-23-CZ

V00251IV2024A

Source(s) of Monetary Support

Pierre Fabre Medicament