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

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04674735

Enrollment

Registered

2020-12-19

Start date

2023-01-01

Completion date

2025-06-01

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meniere Disease, Vertigo, Vertigo Vestibular

Brief summary

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.

Interventions

DRUGAPSLXR

Oral coated tablets once a day for 60 days.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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).

Design outcomes

Primary

Measure	Time frame
Incidence of Adverse Events	during 60 days

Secondary

Measure	Time frame	Description
Pharmacokinetic parameters in steady state	at Day 60	Cmáx\_SS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026