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NCT03110458 · ClinicalTrials.gov registry record · Phase 2
Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
A Phase 2 study, sponsored by Sensorion.
- Completed
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
NCT03110458: Completed Phase 2 study, sponsored by Sensorion.
NCT03110458 is a Phase 2 study that has completed, run by Sensorion. The registered enrollment target is 107 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03110458, a Phase 2 study, has completed, sponsored by Sensorion.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
Study 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)
Primary Outcome
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 wor
Interventions
- DRUG Placebo Oral Tablet
- DRUG SENS-111 100mg
- DRUG SENS-111 200mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2017-08-16 |
| Est. Completion | 2019-10-15 |
| Phase | Phase 2 |
What the finished NCT03110458 record still lists
NCT03110458 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo Oral Tablet is the first listed.
NCT03110458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03110458 about?
NCT03110458 is a clinical study titled "Efficacy of SENS-111 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)
What is the current status of trial NCT03110458?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2017-08-16. Estimated completion is 2019-10-15.
What interventions are being tested in trial NCT03110458?
The interventions under investigation include: Placebo Oral Tablet (DRUG), SENS-111 100mg (DRUG), SENS-111 200mg (DRUG).
Who is sponsoring clinical trial NCT03110458?
This trial is sponsored by Sensorion, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03110458's enrollment target sits among peer trials
107 646th of 2000 higher than 1,353 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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