A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4 days in patients suffering from Acute Unilateral Vestibulopathy (AUV)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
107
SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.
SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.
Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
Columbia University Medical Center
New York, New York, United States
Standing Vertigo Intensity
The primary efficacy endpoint was the Area Under Curve (AUC) for the vertigo intensity measured by the Vertigo Intensity Visual Analogue Scale (VI-VAS) in standing position over the 4 treatment days (8 post-baseline assessments). The vertigo Intensity VAS is a non-anchored 10cm horizontal line. Patients were asked to rate the intensity of their vertigo making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity.
Time frame: over the 4 treatment days
Worst Spontaneous Vertigo Intensity
Worst spontaneous vertigo intensity measured by the AUC of the worst Vertigo Intensity Visual Analogue Scale (VI-VAS) over the 4 treatment days (8 post-baseline assessments). The vertigo Intensity VAS is a non-anchored 10cm horizontal line. Patients were asked to rate the intensity of their vertigo making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity
Time frame: over the 4 treatment days
Proprioception D5
The Romberg test assess the patient's ability to stand unassisted under 6 successive test conditions of increasing difficulty. In this test higher values are indicating a higher ability to stand unassisted, minimum total score is : 0 (impossibility to stand unassisted in any of the six conditions) and maximum is: 6. The change from Baseline of the total score of the six conditions of the Romberg test at the end of treatment (EOT) (Day 5) is evaluated.
Time frame: End of treatment Day 5
Proprioception D28
The Romberg test assess the patient's ability to stand unassisted under 6 successive test conditions of increasing difficulty. In this test higher values are indicating a higher ability to stand unassisted, minimum total score is : 0 (impossibility to stand unassisted in any of the six conditions) and maximum is: 6. Change from Baseline of the total score of the six conditions of the Romberg test at the end of study (EOS) (Day 28) is evaluated.
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University Hospital Hradec Králové
Hradec Králové, Czechia
CHU Gui de Chauliac
Montpellier, France
Hôpital Lariboisière
Paris, France
Kreiskliniken Altötting
Altötting, Bavaria, Germany
Klinikum Unfallkrankenhaus Berlin
Berlin, Germany
Universitätsklinikum Schleswig-Holstein Ratzeburger
Lübeck, Germany
Klinikum der Universität München
Munich, Germany
Bajcsy-Zsilinszky Kórház és Rendelőintézet
Budapest, Hungary
Pécsi Tudományegyetem, ÁOK Klinikai Központ
Pécs, Hungary
...and 14 more locations
Time frame: End of study Day 28
Vestibular Spontaneous Nystagmus D5
Change from Baseline of the Peak Slow Phase Velocity of the Peripheral Vestibular Spontaneous Nystagmus at the end of treatment (EOT) (Day 5). It is intended to record eye movements resulting from Nystagmus, measured by Oculography performed in complete darkness with visual fixation (10 seconds) or without fixation (30 seconds).
Time frame: End of treatment Day 5 compared to basleine
Vestibular Spontaneous Nystagmus D28
Change from Baseline of the Peak Slow Phase Velocity of the Peripheral Vestibular Spontaneous Nystagmus at End of Study (Day 28). It is intended to record eye movements resulting from Nystagmus, measured by Oculography performed in complete darkness with visual fixation (10 seconds) or without fixation (30 seconds).
Time frame: 28 days compared to baseline
Nausea Severity
Nausea Severity measured by the Area under the Curve of the Nausea Intensity Visual Analogue Scale (NI-VAS). Patients were asked to rate the intensity of their nausea making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity.
Time frame: over the 4 Treatment Days (Day 5)