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

Acute Unilateral Vestibulopathy (AUV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110458
• Other study ID #: SENS 111-201
• Status: Completed
• Phase: Phase 2
• Start date: August 16, 2017
• Est. completion date: October 15, 2019

Study information

• Verified date: October 2020
• Source: Sensorion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Unilateral Vestibulopathy (AUV)
• Stress, Psychological

Intervention

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.
• 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 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.

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Králové	Hradec Králové
France	CHU Gui de Chauliac	Montpellier
France	Hôpital Lariboisière	Paris
Germany	Kreiskliniken Altötting	Altötting	Bavaria
Germany	Klinikum Unfallkrankenhaus Berlin	Berlin
Germany	Universitätsklinikum Schleswig-Holstein Ratzeburger	Lübeck
Germany	Klinikum der Universität München	Munich
Hungary	Bajcsy-Zsilinszky Kórház és Rendelointézet	Budapest
Hungary	Pécsi Tudományegyetem, ÁOK Klinikai Központ	Pécs
Hungary	Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ	Szeged
Israel	Soroka Medical Center	Beersheba
Israel	Hillel Yaffe Medical Center	Hadera
Israel	Carmel Medical Center	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petah Tikva
Italy	Ospedale San Raffaele IRCCS	Milano
Korea, Republic of	Chonnam National University Hospital	Donggu
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Chungnam National University Hospital	Junggu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	St. Paul's Hospital, The Catholic University of Korea	Seoul
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sensorion

Countries where clinical trial is conducted

United States,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)