Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
- Conditions
- Acute Unilateral Vestibulopathy (AUV)
- Interventions
- Drug: SENS-111 100mgDrug: SENS-111 200mgDrug: Placebo Oral Tablet
- Registration Number
- NCT03110458
- Lead Sponsor
- Sensorion
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SENS-111 100mg SENS-111 100mg SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo) SENS-111 200mg SENS-111 200mg SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg) Placebo Placebo Oral Tablet Placebo: 2 placebo Oral Dispersible Tablets
- Primary Outcome Measures
Name Time Method Standing Vertigo Intensity over the 4 treatment days 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.
- Secondary Outcome Measures
Name Time Method Worst Spontaneous Vertigo Intensity over the 4 treatment days 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 severityProprioception D5 End of treatment Day 5 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.
Proprioception D28 End of study Day 28 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.
Vestibular Spontaneous Nystagmus D5 End of treatment Day 5 compared to basleine 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).
Vestibular Spontaneous Nystagmus D28 28 days compared to baseline 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).
Nausea Severity over the 4 Treatment Days (Day 5) 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.
Trial Locations
- Locations (24)
Kreiskliniken Altötting
🇩🇪Altötting, Bavaria, Germany
Columbia University Medical Center
🇺🇸New York, New York, United States
University Hospital Hradec Králové
🇨🇿Hradec Králové, Czechia
CHU Gui de Chauliac
🇫🇷Montpellier, France
Hôpital Lariboisière
🇫🇷Paris, France
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
Soroka Medical Center
🇮🇱Beersheba, Israel
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Hungary
Hillel Yaffe Medical Center
🇮🇱Hadera, Israel
Rambam Health Care Campus
🇮🇱Haifa, Israel
Carmel Medical Center
🇮🇱Haifa, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Rabin Medical Center
🇮🇱Petah Tikva, Israel
Ospedale San Raffaele IRCCS
🇮🇹Milano, Italy
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Chonnam National University Hospital
🇰🇷Donggu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Junggu, Korea, Republic of
St. Paul's Hospital, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of