Acute Unilateral Vestibulopathy (AUV)
Conditions
Keywords
Acute unilateral vestibulopathy, AUV
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)
Interventions
DRUGSENS-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.
DRUGSENS-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.
DRUGPlacebo 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.
Sponsors
Sensorion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standing Vertigo Intensity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proprioception D5 | End of treatment Day 5 | 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. |
| Proprioception D28 | End of study Day 28 | 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. |
| Worst Spontaneous Vertigo Intensity | over the 4 treatment days | 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 |
| Vestibular Spontaneous Nystagmus D28 | 28 days compared to baseline | 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). |
| Nausea Severity | over the 4 Treatment Days (Day 5) | 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. |
| Vestibular Spontaneous Nystagmus D5 | End of treatment Day 5 compared to basleine | 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). |
Countries
Czechia, France, Germany, Hungary, Israel, Italy, South Korea, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 37 |
| 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. | 36 |
| 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. | 34 |
| Total | 107 |
Baseline characteristics
| Characteristic | SENS-111 100mg | SENS-111 200mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 12.89 | 51.6 years STANDARD_DEVIATION 14.14 | 51.1 years STANDARD_DEVIATION 2.82 | 50.7 years STANDARD_DEVIATION 13.21 |
| Body Weight | 82.2 Kg STANDARD_DEVIATION 22.1 | 81.6 Kg STANDARD_DEVIATION 18.9 | 80.1 Kg STANDARD_DEVIATION 16.37 | 81.3 Kg STANDARD_DEVIATION 18.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 21 Participants | 19 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 17 Participants | 15 Participants | 15 Participants | 47 Participants |
| Sex: Female, Male Female | 14 Participants | 8 Participants | 11 Participants | 33 Participants |
| Sex: Female, Male Male | 23 Participants | 28 Participants | 23 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 36 | 0 / 32 |
| other Total, other adverse events | 4 / 36 | 5 / 36 | 7 / 32 |
| serious Total, serious adverse events | 0 / 36 | 1 / 36 | 0 / 32 |
Outcome results
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.
Time frame: over the 4 treatment days
Population: Among the patients who started the study data was missing for some patients: 3 SENS-111 100mg, 1 SENS-111 200mg, 3 placebo patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SENS-111 100mg | Standing Vertigo Intensity | 165.10 mm*day | Standard Deviation 71.02 |
| SENS-111 200mg | Standing Vertigo Intensity | 155.10 mm*day | Standard Deviation 83.06 |
| Placebo | Standing Vertigo Intensity | 136.60 mm*day | Standard Deviation 62.61 |
p-value: 0.8466ANCOVA
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.
Time frame: over the 4 Treatment Days (Day 5)
Population: Among the patients who started the study data was missing for some patients: 3 SENS-111 100mg, 1 SENS-111 200mg, 3 placebo patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SENS-111 100mg | Nausea Severity | 93.00 mm*day | Standard Deviation 78.39 |
| SENS-111 200mg | Nausea Severity | 91.50 mm*day | Standard Deviation 79.73 |
| Placebo | Nausea Severity | 92.60 mm*day | Standard Deviation 57.28 |
p-value: 0.5324ANCOVA
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.
Time frame: End of study Day 28
Population: Among the patients who started the study data was missing for some patients: 7 SENS-111 100mg, 3 SENS-111 200mg, 8 placebo patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SENS-111 100mg | Proprioception D28 | 2.70 score on a scale | Standard Deviation 1.6 |
| SENS-111 200mg | Proprioception D28 | 3.00 score on a scale | Standard Deviation 1.64 |
| Placebo | Proprioception D28 | 3.20 score on a scale | Standard Deviation 1.46 |
p-value: 0.393ANCOVA
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.
Time frame: End of treatment Day 5
Population: Among the patients who started the study data was missing for some patients: 5 SENS-111 100mg, 4 SENS-111 200mg, 8 placebo patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SENS-111 100mg | Proprioception D5 | 2.10 score on a scale | Standard Deviation 1.46 |
| SENS-111 200mg | Proprioception D5 | 2.00 score on a scale | Standard Deviation 1.79 |
| Placebo | Proprioception D5 | 2.40 score on a scale | Standard Deviation 1.45 |
p-value: 0.3166ANCOVA
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).
Time frame: 28 days compared to baseline
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SENS-111 100mg | Vestibular Spontaneous Nystagmus D28 | with fixation (10 seconds) | -4.80 degrees per second | Standard Deviation 15.1 |
| SENS-111 100mg | Vestibular Spontaneous Nystagmus D28 | without fixation (30 seconds) | -0.8 degrees per second | Standard Deviation 8.84 |
| SENS-111 200mg | Vestibular Spontaneous Nystagmus D28 | with fixation (10 seconds) | -7.9 degrees per second | Standard Deviation 12.76 |
| SENS-111 200mg | Vestibular Spontaneous Nystagmus D28 | without fixation (30 seconds) | -2.9 degrees per second | Standard Deviation 8.96 |
| Placebo | Vestibular Spontaneous Nystagmus D28 | with fixation (10 seconds) | -7.7 degrees per second | Standard Deviation 11.59 |
| Placebo | Vestibular Spontaneous Nystagmus D28 | without fixation (30 seconds) | -2.7 degrees per second | Standard Deviation 6.5 |
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).
Time frame: End of treatment Day 5 compared to basleine
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SENS-111 100mg | Vestibular Spontaneous Nystagmus D5 | with fixation (10 seconds) | -2.30 degrees per second | Standard Deviation 11.64 |
| SENS-111 100mg | Vestibular Spontaneous Nystagmus D5 | without fixation (30 seconds) | -1.2 degrees per second | Standard Deviation 5.77 |
| SENS-111 200mg | Vestibular Spontaneous Nystagmus D5 | with fixation (10 seconds) | -3.50 degrees per second | Standard Deviation 10.27 |
| SENS-111 200mg | Vestibular Spontaneous Nystagmus D5 | without fixation (30 seconds) | -2.2 degrees per second | Standard Deviation 7.22 |
| Placebo | Vestibular Spontaneous Nystagmus D5 | with fixation (10 seconds) | -5.7 degrees per second | Standard Deviation 8.15 |
| Placebo | Vestibular Spontaneous Nystagmus D5 | without fixation (30 seconds) | -2.7 degrees per second | Standard Deviation 5.22 |
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
Time frame: over the 4 treatment days
Population: Among the patients who started the study data was missing for some patients: 6 SENS-111 100mg, 4 SENS-111 200mg, 7 placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SENS-111 100mg | Worst Spontaneous Vertigo Intensity | 180.10 mm*day | Standard Deviation 67.2 |
| SENS-111 200mg | Worst Spontaneous Vertigo Intensity | 170.40 mm*day | Standard Deviation 89.83 |
| Placebo | Worst Spontaneous Vertigo Intensity | 140.8 mm*day | Standard Deviation 64.66 |
p-value: 0.9538ANCOVA