Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy

Sensorion

Status and phase: Completed; Phase 2

Conditions: Acute Unilateral Vestibulopathy (AUV)

Treatments: Drug: Placebo Oral Tablet; Drug: SENS-111 200mg; Drug: SENS-111 100mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03110458

SENS 111-201

Details and patient eligibility

About

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)

Enrollment: 107 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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107 participants in 3 patient groups, including a placebo group

SENS-111 100mg

Experimental group

Description:

SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)

Treatment:

Drug: SENS-111 100mg

SENS-111 200mg

Experimental group

Description:

SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)

Treatment:

Drug: SENS-111 200mg

Placebo

Placebo Comparator group

Description:

Placebo: 2 placebo Oral Dispersible Tablets

Treatment:

Drug: Placebo Oral Tablet