Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease

Apsen Farmaceutica

Status and phase: Withdrawn; Phase 1

Conditions: Vertigo; Meniere Disease; Vertigo Vestibular

Treatments: Drug: APSLXR

Study type: Interventional

Funder types: Industry

Identifiers

NCT04674735

APS004/2020

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of APSLXR in participants with Meniere's disease or other Verigo of vestibular origin. Pharmacokinetics will also be evaluated in a small group.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Meniere's Disease or Vertigo of Vestibular Origin;
• Voluntarily consent to participate in the study;

Exclusion criteria

• Female patients who are pregnant or breastfeeding;
• Participants presenting uncontroled systolic hipertension (>140/90 mmHg);
• Participants presenting uncontroled diabetes (blood glucose >200 mg/dL).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

APSLXR

Experimental group

Treatment:

Drug: APSLXR