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

NCT03110458 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: SENS 111-201
• Study Type: interventional
• Target: 107
• Locations: 8 countries
• Sites: 24

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)

Conditions

Acute Unilateral Vestibulopathy (AUV)

Keywords

Acute unilateral vestibulopathy, AUV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Worst Spontaneous Vertigo Intensity

  over the 4 treatment days

• Proprioception D5

  End of treatment Day 5

• Proprioception D28

  End of study Day 28

• Vestibular Spontaneous Nystagmus D5

  End of treatment Day 5 compared to basleine

• Vestibular Spontaneous Nystagmus D28

  28 days compared to baseline

Study Arms (3)

SENS-111 100mg

EXPERIMENTAL

SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)

Drug: SENS-111 100mg

SENS-111 200mg

EXPERIMENTAL

SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)

Drug: SENS-111 200mg

Placebo

PLACEBO COMPARATOR

Placebo: 2 placebo Oral Dispersible Tablets

Drug: Placebo Oral Tablet

Interventions

SENS-111 100mg DRUG

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 100mg

SENS-111 200mg DRUG

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.

SENS-111 200mg

Placebo Oral Tablet DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* Subject has a diagnosis of definite Acute Unilateral Vestibulopathy

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensorion: lead

Study Sites (24)

Columbia University Medical Center

New York, New York, 10032, United States

Location

University Hospital Hradec Králové

Hradec Králové, 50005, Czechia

Location

CHU Gui de Chauliac

Montpellier, 34295, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Kreiskliniken Altötting

Altötting, Bavaria, 84503, Germany

Location

Klinikum Unfallkrankenhaus Berlin

Berlin, 12683, Germany

Location

Universitätsklinikum Schleswig-Holstein Ratzeburger

Lübeck, 23538, Germany

Location

Klinikum der Universität München

Munich, 81377, Germany

Location

Bajcsy-Zsilinszky Kórház és Rendelőintézet

Budapest, 1106, Hungary

Location

Pécsi Tudományegyetem, ÁOK Klinikai Központ

Pécs, 7621, Hungary

Location

Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ

Szeged, 6725, Hungary

Location

Soroka Medical Center

Beersheba, 84101, Israel

Location

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Carmel Medical Center

Haifa, 3436212, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

Ospedale San Raffaele IRCCS

Milan, 20132, Italy

Location

Chonnam National University Hospital

Donggu, 61469, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Chungnam National University Hospital

Junggu, 35015, South Korea

Location

St. Paul's Hospital, The Catholic University of Korea

Seoul, 02559, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

MeSH Terms

Interventions

seliforant

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Sensorion

contact@sensorion-pharma.com

+33 4 67 20 77 30

Study Officials

• Michael STRUPP, MD

  University Hospital Munich

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 12, 2017
• Study Start: August 16, 2017
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: October 27, 2020
• Results First Posted: October 27, 2020

Record last verified: 2020-10

Locations

FR (2); IL (6); US (1); CZ (1); DE (4); HU (3); IT (1); KR (6)