Clinical trial NCT03110458: Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Unilateral Vestibulopathy (AUV)
Keywords: Acute unilateral vestibulopathy, AUV
Lead sponsor: Sensorion
Sponsor class: INDUSTRY
First posted: 2017-04-12
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Standing Vertigo Intensity
timeFrame: over the 4 treatment days
Secondary outcomes:
measure: Worst Spontaneous Vertigo Intensity
timeFrame: over the 4 treatment days
measure: Proprioception D5
timeFrame: End of treatment Day 5
measure: Proprioception D28
timeFrame: End of study Day 28
measure: Vestibular Spontaneous Nystagmus D5
timeFrame: End of treatment Day 5 compared to basleine
measure: Vestibular Spontaneous Nystagmus D28
timeFrame: 28 days compared to baseline
measure: Nausea Severity
timeFrame: over the 4 Treatment Days (Day 5)
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Králové
city: Montpellier
country: France
facility: CHU Gui de Chauliac
city: Paris
country: France
facility: Hôpital Lariboisière
city: Altötting
country: Germany
facility: Kreiskliniken Altötting
state: Bavaria
city: Berlin
country: Germany
facility: Klinikum Unfallkrankenhaus Berlin
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Ratzeburger
city: Munich
country: Germany
facility: Klinikum der Universität München
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház és Rendelőintézet
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem, ÁOK Klinikai Központ
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ
city: Beersheba
country: Israel
facility: Soroka Medical Center
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Milano
country: Italy
facility: Ospedale San Raffaele IRCCS
city: Donggu
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Junggu
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: St. Paul's Hospital, The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: University Hospital Munich
name: Michael STRUPP, MD
role: PRINCIPAL_INVESTIGATOR
References: