Acute Unilateral Vestibulopathy (AUV)Phase 2NCT03110458
Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
A Phase 2 study testing SENS-111 100mg and SENS-111 200mg in people with Acute Unilateral Vestibulopathy (AUV), run by Sensorion at 24 sites in 8 countries.
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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Unilateral Vestibulopathy (AUV)
- What is being tested?
- SENS-111 100mg and SENS-111 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 24 sitesin 8 countries
- Study dates
- 16 Aug 2017to 15 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a diagnosis of definite Acute Unilateral Vestibulopathy
Who cannot join
- 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
Trial locations and contacts
24 sites in 8 countries.
24 sites in 8 countries
Israel6 sites
Soroka Medical Center
Beersheba, 84101
Hillel Yaffe Medical Center
Hadera, 38100
Rambam Health Care Campus
Haifa, 3109601
Carmel Medical Center
Haifa, 3436212
Meir Medical Center
Kfar Saba, 4428164
Rabin Medical Center
Petah Tikva, 4941492
South Korea6 sites
Chonnam National University Hospital
Donggu, 61469
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Chungnam National University Hospital
Junggu, 35015
St. Paul's Hospital, The Catholic University of Korea
Seoul, 02559
Asan Medical Center
Seoul, 05505
Gangnam Severance Hospital
Seoul, 06273
Germany4 sites
Kreiskliniken Altötting
Altötting, Bavaria, 84503
Klinikum Unfallkrankenhaus Berlin
Berlin, 12683
Universitätsklinikum Schleswig-Holstein Ratzeburger
Lübeck, 23538
Klinikum der Universität München
Munich, 81377
Hungary3 sites
Bajcsy-Zsilinszky Kórház és Rendelőintézet
Budapest, 1106
Pécsi Tudományegyetem, ÁOK Klinikai Központ
Pécs, 7621
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ
Szeged, 6725
France2 sites
CHU Gui de Chauliac
Montpellier, 34295
Hôpital Lariboisière
Paris, 75010
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
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
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)
- Being tested
- SENS-111 100mg, SENS-111 200mg, Placebo Oral Tablet
- Keywords
- Acute unilateral vestibulopathy, AUV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENS-111 100mgDrug
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 200mgDrug
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 TabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SENS-111 100mg | Experimental | SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo) Receives: Drug: SENS-111 100mg |
| SENS-111 200mg | Experimental | SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg) Receives: Drug: SENS-111 200mg |
| Placebo | Placebo comparator | Placebo: 2 placebo Oral Dispersible Tablets Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: over the 4 treatment days
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: over the 4 Treatment Days (Day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start16 Aug 2017
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Unilateral Vestibulopathy (AUV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensorion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael STRUPP, MD, Principal investigator, University Hospital Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110458
- Sponsor's protocol ID
- SENS 111-201
- Status last verified
- Oct 2020
- First submitted
- 27 Mar 2017
- Last updated
- 27 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03110458
- Acronym / sponsor ID
- SENS 111-201
- Conditions
- Acute Unilateral Vestibulopathy (AUV)
- Keywords
- Acute unilateral vestibulopathy, AUV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- SensorionIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 27 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SENS-111 100mg | Experimental | Drug: SENS-111 100mgSENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo) |
| SENS-111 200mg | Experimental | Drug: SENS-111 200mgSENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg) |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo: 2 placebo Oral Dispersible Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject has a diagnosis of definite Acute Unilateral Vestibulopathy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENS-111 100mgSENS-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. | Drug | SENS-111 100mg |
| SENS-111 200mgSENS-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. | Drug | SENS-111 200mg |
| Placebo Oral TabletPlacebo 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. | Drug | Placebo |
Primary outcome
Standing Vertigo Intensity
Time frame: over the 4 treatment days
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.
6 secondary outcomes
Worst Spontaneous Vertigo Intensity
Time frame: over the 4 treatment days
Proprioception D5
Time frame: End of treatment Day 5
Proprioception D28
Time frame: End of study Day 28
Vestibular Spontaneous Nystagmus D5
Time frame: End of treatment Day 5 compared to basleine
Vestibular Spontaneous Nystagmus D28
Time frame: 28 days compared to baseline
Nausea Severity
Time frame: over the 4 Treatment Days (Day 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acute Unilateral Vestibulopathy (AUV)
Not yet recruiting
Quantitative Eye Movement Measurements in Patients with Acute Vestibular Syndrome
Acute Vestibular Syndrome, Vertigo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael STRUPP, MD principal investigator
University Hospital Munich
24 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SENS-111 100mg and SENS-111 200mg in people with Acute Unilateral Vestibulopathy (AUV), run by Sensorion at 24 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Israel, South Korea, Germany, Hungary, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standing Vertigo Intensity (time frame: over the 4 treatment days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.