Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 2 Dose Regimens of Orally Administered SENS-111 (100 mg and 200 mg) Given During 4 Days in Patients Suffering From Acute Unilateral Vestibulopathy

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 Overview

• Status: Completed
• Conditions: Acute Unilateral Vestibulopathy (AUV)
• Intervention / Treatment: Drug: SENS-111 100mg; Drug: SENS-111 200mg; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Hradec Králové, Czechia, 50005
    • University hospital Hradec Králové
• France
  • Montpellier, France, 34295
    • CHU Gui de Chauliac
  • Paris, France, 75010
    • Hopital Lariboisiere
• Germany
  • Berlin, Germany, 12683
    • Klinikum Unfallkrankenhaus Berlin
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein Ratzeburger
  • Munich, Germany, 81377
    • Klinikum der Universität München
  • Bavaria
    • Altötting, Bavaria, Germany, 84503
      • Kreiskliniken Altötting
• Hungary
  • Budapest, Hungary, 1106
    • Bajcsy-Zsilinszky Korhaz es Rendelointezet
  • Pécs, Hungary, 7621
    • Pécsi Tudományegyetem, ÁOK Klinikai Központ
  • Szeged, Hungary, 6725
    • Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ
• Israel
  • Beersheba, Israel, 84101
    • Soroka Medical Center
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Haifa, Israel, 3436212
    • Carmel Medical Center
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center
• Italy
  • Milano, Italy, 20132
    • Ospedale San Raffaele IRCCS
• Korea, Republic of
  • Donggu, Korea, Republic of, 61469
    • Chonnam National University Hospital
  • Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Junggu, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of, 02559
    • St. Paul's Hospital, The Catholic University of Korea
• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria includes, but is not limited to:

* Subject has a diagnosis of definite Acute Unilateral Vestibulopathy

Exclusion criteria includes, but is not limited to:

• Acute continuous vertigo lasting more than 72 hours prior to randomization
• History of acute or chronic vestibular diseases
• History of prior acute central vestibular lesion
• Acute or chronic disease of middle ear

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SENS-111 100mg; SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)	Drug: SENS-111 100mg; 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.
EXPERIMENTAL: SENS-111 200mg; SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)	Drug: SENS-111 200mg; 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_COMPARATOR: Placebo; Placebo: 2 placebo Oral Dispersible Tablets	Drug: Placebo Oral Tablet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	over the 4 treatment days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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).	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).	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.	over the 4 Treatment Days (Day 5)

Collaborators and Investigators

• Sponsor: Sensorion
• Investigators: Principal Investigator: Michael STRUPP, MD, University Hospital Munich

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 16, 2017
• Primary Completion (ACTUAL): October 15, 2019
• Study Completion (ACTUAL): October 15, 2019

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (ACTUAL): April 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Acute unilateral vestibulopathy, AUV
• Other Study ID Numbers: SENS 111-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No