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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SENS-111 100mg | Experimental | SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo) |
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| SENS-111 200mg | Experimental | SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg) |
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| Placebo | Placebo Comparator | Placebo: 2 placebo Oral Dispersible Tablets |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Michael STRUPP, MD | University Hospital Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States | ||
| University Hospital Hradec Králové |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 12, 2019 | Jul 20, 2020 |
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| 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. |
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| 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. |
|
| 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. | 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. | 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). | 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). | 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. | over the 4 Treatment Days (Day 5) |
| Hradec Králové |
| 50005 |
| Czechia |
| CHU Gui de Chauliac | Montpellier | 34295 | France |
| Hôpital Lariboisière | Paris | 75010 | France |
| Kreiskliniken Altötting | Altötting | Bavaria | 84503 | Germany |
| Klinikum Unfallkrankenhaus Berlin | Berlin | 12683 | Germany |
| Universitätsklinikum Schleswig-Holstein Ratzeburger | Lübeck | 23538 | Germany |
| Klinikum der Universität München | Munich | 81377 | Germany |
| Bajcsy-Zsilinszky Kórház és Rendelőintézet | Budapest | 1106 | Hungary |
| Pécsi Tudományegyetem, ÁOK Klinikai Központ | Pécs | 7621 | Hungary |
| Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ | Szeged | 6725 | Hungary |
| Soroka Medical Center | Beersheba | 84101 | Israel |
| Hillel Yaffe Medical Center | Hadera | 38100 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Carmel Medical Center | Haifa | 3436212 | Israel |
| Meir Medical Center | Kfar Saba | 4428164 | Israel |
| Rabin Medical Center | Petah Tikva | 4941492 | Israel |
| Ospedale San Raffaele IRCCS | Milan | 20132 | Italy |
| Chonnam National University Hospital | Donggu | 61469 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Chungnam National University Hospital | Junggu | 35015 | South Korea |
| St. Paul's Hospital, The Catholic University of Korea | Seoul | 02559 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| FG001 | 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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Body Weight | Mean | Standard Deviation | Kg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Among the patients who started the study data was missing for some patients: 3 SENS-111 100mg, 1 SENS-111 200mg, 3 placebo patients | Posted | Mean | Standard Deviation | mm*day | over the 4 treatment days |
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| 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 | Among the patients who started the study data was missing for some patients: 6 SENS-111 100mg, 4 SENS-111 200mg, 7 placebo | Posted | Mean | Standard Deviation | mm*day | over the 4 treatment days |
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| 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. | Among the patients who started the study data was missing for some patients: 5 SENS-111 100mg, 4 SENS-111 200mg, 8 placebo patients | Posted | Mean | Standard Deviation | score on a scale | End of treatment Day 5 |
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| 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. | Among the patients who started the study data was missing for some patients: 7 SENS-111 100mg, 3 SENS-111 200mg, 8 placebo patients | Posted | Mean | Standard Deviation | score on a scale | End of study Day 28 |
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| 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). | Among the patients who started the study data was missing for some patients: with fixation 13 SENS-111 100mg, 10 SENS-111 200mg, 11 placebo patients; without fixation 13 SENS-111 100mg, 13 SENS-111 200mg, 13 placebo patients | Posted | Mean | Standard Deviation | degrees per second | End of treatment Day 5 compared to basleine |
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| 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). | Among the patients who started the study data was missing for some patients: with fixation 11 SENS-111 100mg, 10 SENS-111 200mg, 12 placebo patients ; without fixation 12 SENS-111 100mg, 12 SENS-111 200mg, 13 placebo patients | Posted | Mean | Standard Deviation | degrees per second | 28 days compared to baseline |
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| 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. | Among the patients who started the study data was missing for some patients: 3 SENS-111 100mg, 1 SENS-111 200mg, 3 placebo patients | Posted | Mean | Standard Deviation | mm*day | over the 4 Treatment Days (Day 5) |
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up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects).
Treatment emergent adverse events are displayed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 36 | 0 | 36 | 4 | 36 |
| EG001 | 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. | 0 | 36 | 1 | 36 | 5 | 36 |
| EG002 | 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. | 0 | 32 | 0 | 32 | 7 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticular perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extra dose administered | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Folate deficiency | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Regulatory Affairs | Sensorion | +33 4 67 20 77 30 | contact@sensorion-pharma.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 9, 2017 | Jul 21, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| C000654667 | seliforant |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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