Phase 2
N=107
Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
Acute Unilateral Vestibulopathy (AUV)
Bottom Line
View on ClinicalTrials.gov: NCT03110458 ↗Enrolled (actual)
107
Serious AEs
1.0%
Results posted
Oct 2020
Primary outcome: Primary: Standing Vertigo Intensity — 165.10; 155.10; 136.60 mm*day — p=0.8466
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SENS-111 100mg (Drug); SENS-111 200mg (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sensorion
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standing Vertigo Intensity |
165.10; 155.10; 136.60 | 0.8466 |
| SECONDARY Worst Spontaneous Vertigo Intensity |
180.10; 170.40; 140.8 | 0.9538 |
| SECONDARY Proprioception D5 |
2.10; 2.00; 2.40 | 0.3166 |
| SECONDARY Proprioception D28 |
2.70; 3.00; 3.20 | 0.393 |
| SECONDARY Vestibular Spontaneous Nystagmus D5 |
-2.30; -3.50; -5.7; -1.2; -2.2; -2.7 | — |
| SECONDARY Vestibular Spontaneous Nystagmus D28 |
-4.80; -7.9; -7.7; -0.8; -2.9; -2.7 | — |
| SECONDARY Nausea Severity |
93.00; 91.50; 92.60 | 0.5324 |
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
Data sourced from ClinicalTrials.gov (NCT03110458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.