Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
NCT ID: NCT03110458
Last Updated: 2020-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
107 participants
INTERVENTIONAL
2017-08-16
2019-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SENS-111 100mg
SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)
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: 2 Oral Dispersible Tablets (SENS-111 100 mg)
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
Placebo: 2 placebo Oral Dispersible Tablets
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of acute or chronic vestibular diseases
* History of prior acute central vestibular lesion
* Acute or chronic disease of middle ear
18 Years
75 Years
ALL
No
Sponsors
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Sensorion
INDUSTRY
Responsible Party
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Principal Investigators
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Michael STRUPP, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Munich
Locations
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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
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
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ
Szeged, , Hungary
Soroka Medical Center
Beersheba, , Israel
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
Milan, , Italy
Chonnam National University Hospital
Donggu, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Chungnam National University Hospital
Junggu, , South Korea
St. Paul's Hospital, The Catholic University of Korea
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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SENS 111-201
Identifier Type: -
Identifier Source: org_study_id