Acute Unilateral Vestibulopathy MedDRA version: 20.1 Level: PT Classification code 10047393 Term: Vestibular neuronitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: SENS-111
Product Code: SENS-111
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: Not yet assigned
CAS Number: 1164115-89-2
Current Sponsor code: SENS-111
Other descriptive
Sponsors
Sensorion SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients 2. Aged =18 years and 25% according to the caloric test (de Jongkees’ formula). 4. Affiliated or is a beneficiary to a health insurance system (if applicable in the national regulations) 5. Signed and dated written informed consent. 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 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Vertigo duration of less than 6 hours before randomization 2. Acute continuous vertigo lasting more than 72 hours prior to randomization 3. Acute hearing loss during or after the onset of vertigo. 4. Acute unilateral tinnitus during or after the onset of vertigo 5. History of acute or chronic vestibular diseases (including Ménière’s disease, acute labyrinthitis, vestibular migraine...), vestibular dysfunction, previous episode of acute unilateral vestibulopathy or prolonged vertigo. 6. Ongoing Benign paroxysmal positional vertigo (BPPV) 7. History of prior acute central vestibular lesion. 8. Acute or chronic disease of middle ear (infections, otitis) 9. Concurrent Varicella Zoster Virus (VZV) ear infection (Herpes zoster oticus) 10. History of cochlear implants 11. Neurological disorders including stroke, brainstem or cerebellar dysfunction within the last 3 months (In case of possible stroke of the brainstem or cerebellum, the diagnosis should have been excluded by a MRI performed in the past 48 hours) 12. Past or concomitant treatment with ototoxic chemotherapy 13. Past history of seizures or convulsions 14. Head trauma within the last 10 days prior to randomization 15. Aminoglycosides in the past 6 months given via systemic or transtympanic administration 16. Concomitant treatment with any of the followings within the last 24 hours prior to randomization if more than 3 doses have been taken: a. Antihistamines: diphenhydramine, cyclizine, dimenhydrinate, meclizine, hydroxyzine, promethazine, b. Cinnarizine, flunarizine c. Central anti-dopaminergics: neuroleptics, unless the dose is stable for at least 1 month prior to randomization and no changes are expected during the course of the study d. Benzodiazepines e. Histaminergics (e.g., betahistine) f. Scopolamine, homatropine g. Gabapentin, pregabalin h. Acetylleucine, 5HT3 antagonists (ondensetron, granisetron, palonosetron etc..) i. Piracetam, piribedil, trimetazidine, j. Corticosteroids (oral or injectable) unless the dose is stable for at least 1 month prior to randomization and no changes are expected during the course of the study 17. Treatment with any investigational agent within 4 weeks prior to randomization or 5 half-lives of the investigational drug (whichever is longer) 18. Prior participation in a clinical trial with SENS-111 19. History of malignancy other than effectively treated carcinoma in-situ of the cervix, or adequately treated non-metastatic squamous or basal cell carcinoma of the skin, within 5 years 20. Known history of, or concomitant severe hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological, renal, or dermatological disease, or any condition, psychiatric, substance abuse, or otherwise, that, in the opinion of the Investigator might interfere with the evaluation of study treatment or warrant exclusion. 21. Pregnancy (a negative pregnancy test is required for all women of childbearing potential (WOCBP) before initiation of treatment 22. Male and female patients of child-bearing potential who are unwilling to use an highly effective contraception while enrolled on study and receiving the experimental drug, and for at least 1 month after the last intake of the investigational product. Highly effective therapy includes a. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal b. Pro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of SENS-111 in Acute Unilateral Vestibulopathy (AUV);Secondary Objective: -to explore the effect of SENS-111 on quality of life - to determine the optimal dose regimen for SENS-111 - to evaluate safety and tolerability of SENS-111 in patients with AUV - to evaluate the effect of SENS-111 on long term recovery of vestibular function -to characterize the plasma exposure to SENS-111 in patients with AUV -to preliminary evaluate the health economics of SENS-111;Primary end point(s): The primary endpoint is the vertigo intensity measured by the AUC of the Vertigo Intensity Visual Analogue Scale (VI-VAS) in standing position over the 4 treatment days (8 post baseline assessments);Timepoint(s) of evaluation of this end point: Over the 4 treatment days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - worst spontaneous vertigo intensity measured by the AUC of the worst vertigo visual analogue scale (VI-VAS) over the 4 treatment days (8 hours post baseline assessment) - Change from baseline of the total score of the Romberg tests at the end of the treatment (D5) and end of study (D28) - Peak slow phase velocity of the peripheral vestibular spontaneous nystagmus, measured by oculography in darkness at the end of treatment (D5) and the end of study (D28) -Nausea intensity measured by the AUC of the Nausea Intensity Visual Analogue Scale over the 4 treatment days (8post baseline assessments) - The functional disability at the end of study (D28) assessed by the Dizziness Handicap Inventory (DHI) functional subscale score and the Vestibular Disorder Activities of Daily Living Scale (VADL);Timepoint(s) of evaluation of this end point: - worst spontaneous vertigo intensity: over the 4 treatment days (8 hours post baseline assessment) - Change from baseline of the total score of the Romberg tests at the end of the treatment (D5) and end of study (D28) - Peak slow phase velocity of the peripheral vestibular spontaneous nystagmus: at the end of treatment (D5) and the end of study (D28) -Nausea intensity: over the 4 treatment days (8 post baseline assessments) - The functional disability at the end of study (D28) assessed by the Dizziness Handicap Inventory (DHI) functional subscale score and the Vestibular Disorder Activities of Daily Living Scale (VADL) | — |
Countries
Czech Republic, Germany, Hungary, Korea, Democratic People's Republic of, Poland, Spain, United States
Contacts
Public ContactJudith LAREDO
Sensorion SA
Outcome results
None listed