The aim of this exploratory study is to assess the efficacy of the L-enantiomer V0251 oral form in the treatment of acute episodes of vertigo. MedDRA version: 14.1 Level: PT Classification code 10047393 Term: Vestibular neuronitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: L-acetylleucine
Product Code: V0251 ST 01A
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: L-acetylleucine
CAS Number: 1188-21-2
Current Sponsor code: V0251
Other
Sponsors
PIERRE FABRE MEDICAMENT -IRPF- PIERRE FABRE INNOVATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age 18 to 80 years, included -Acute vestibular neuritis, defined as: - Acute or subacute onset of severe, prolonged rotatory vertigo, nausea and postural imbalance that began within 48 hours before randomization (i.e.first treatment administration) -Horizontal spontaneous nystagmus with a rotational component toward the unaffected ear (fast phase) -Suppression or reduction of the nystagmus by visual fixation -Horizontal gaze-evoked nystagmus (i.e. increase of the nystagmus with gaze directed toward the fast phase of the spontaneous nystagmus and a decrease with gaze directed toward the slow phase) -Horizontal head impulse test showing an ipsilateral deficit (i.e. rotation of the head toward the affected ear inducing catch-up saccade toward the unaffected ear) -No skew deviation at the cover test for skew (i.e. no vertical misalignment of the visual axes during ocular alternate cover testing) -For woman of child bearing potential: negative urine 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 randomization (i.e. first treatment administration) 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 Form could 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 within 2 days (specifically for Israel, in case of intense vertigo, the Informed Consent Form could be read to the patient by the third party and then must be signed by the patient together with the third party before performing any study procedure). -Likely to be compliant during the study, in the judgement of the investigator -Affiliated to a social security or health insurance system, or is a beneficiary (if applicable in the 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 84 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84
Exclusion criteria
Exclusion criteria: Target disease characteristics: -Onset of acute vestibular neuritis more than 2 days before randomization (i.e. first study treatment administration)Other diseases: -Acute, unilateral tinnitus, during or after the onset of vertigo -Acute hearing loss, during or after the onset of vertigo - Acute pressure sensation in the ear, during or after the onset of vertigo - Acute tympanic membrane perforation - Recent history of ear and/or head trauma - Previous episodes of vestibular neuritis or prolonged vertigo (compatible with an episode of vestibular neuritis according to investigator’s judgement) -Signs of central vestibular lesion in the history and in the clinical evaluation (e.g. pure vertical and/or torsional nystagmus, change of nystagmus direction on eccentric gaze away from the direction of the quick phase) -Signs of brain, brainstem and/or cerebellar dysfunction (e.g. perioral hypoesthesia, facial paresis/palsy, dysphagia, dysarthria, limb paresis and/or hypesthesia, coordination deficit, confusion/loss of consciousness) -Ménière’s disease -Benign paroxysmal positioning vertigo -Chronic vestibular dysfunction -Vestibular migraine -Chronic otitis -History of hypersensitivity to acetylleucine or excipients -History of hypersensitivity to gluten -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 or is likely to modify his / her handling of the study drug Relating to treatments: -History of systemic or transtympanic administration of aminoglycosides or any other ototoxic substances such as gentamicin, streptomycin, quinine, mefloquine or methotrexate -Use of the following medications within the last 12 hours prior to baseline evaluations (i.e. scales completion and nystagmus measurements ):-Antihistamines: diphenhydramine, cyclizine, dimenhydrinate, meclozine, hydroxyzine, promethazine -Calcium antagonists: cinnarizine, flunarizine -Central antidopaminergics: neuroleptics (benzodiazepines and non-benzodiazepines), except if their dosage is stable for at least one month before the inclusion -Peripheral antidopaminergics: metoclopramide, alizapride -Histaminergics: betahistine -Anticholinergics: scopolamine (hyoscine), homatropine -GABA agonists: gabapentin, pregabalin -Acetylleucine, piribedil, ondansetron, piracetam, trimetazidine, ginkgo biloba -Steroids, except inhaled steroids if their dosage is stable for at least one month before the inclusion Others: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine the efficacy of the daily administration of 8g of V0251 by oral route during 14 days on vertigo symptom relief in patients suffering from acute vestibular neuritis.;Secondary Objective: The secondary objectives of the study are: - To determine the efficacy of the daily administration of 8g of V0251 by oral route during 14 days on central vestibular compensation in patient suffering from acute vestibular neuritis, - To determine the tolerance of the daily administration of 8g of V0251 by oral route during 14 days in patient suffering from acute vestibular neuritis. ;Primary end point(s): VSS-SF (Vertigo Symptom Scale) and VRS (Verbal Rating scale);Timepoint(s) of evaluation of this end point: The primary endpoint was the change of spontaneous nystagmus scores muesured by videonystagmpgraphy with patient in complete darkness looking straight ahead with Day 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The main secondary parameter was the measure of the change of vertigo symptoms measured by a validated vertigo symptoms measured by a validated symptom scale, the European Evaluation of Vertigo (EEV, ranging from 0 to 20).;Timepoint(s) of evaluation of this end point: European Evaluation of Vertigo (EEV, ranging from 0 to 20). | — |
Countries
Czech Republic, France, Germany, Hungary, Israel, Italy, Russian Federation, Spain
Contacts
Public ContactLudovic Couillard
PharmaNet, Ltd. UK
Outcome results
None listed