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

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.

Why the study stopped: Cancelled by Sponsor

Withdrawn

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Key information

Conditions

Meniere Disease Ear Diseases Endolymphatic Hydrops Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertigo Vertigo Vestibular Vestibular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

APSLXR

Drug

Oral coated tablets once a day for 60 days.

Primary outcomes

Incidence of Adverse Events

Time frame: during 60 days

Secondary outcomes

Pharmacokinetic parameters in steady state

Time frame: at Day 60

Cmáx_SS

Sponsors and collaborators

Lead sponsor

Apsen Farmaceutica S.A.

Industry

Registry information

Official study title

Multicentre, Open Label, Phase I Clinical Trial to Evaluate the Safety of APSLXR for the Treatment of Vertigo of Vestibular Origin or Meniere's Disease

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Dec 19, 2020
Registry last updated: Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed