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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Meniere Disease Vertigo Vertigo Vestibular

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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APSLXR

Group Type EXPERIMENTAL

APSLXR

Intervention Type DRUG

Oral coated tablets once a day for 60 days.

Interventions

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APSLXR

Oral coated tablets once a day for 60 days.

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No