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

Phase 1

Withdrawn

• Conditions: Meniere Disease; Vertigo; Vertigo Vestibular
• Interventions: Drug: APSLXR

• Registration Number: NCT04674735
• Lead Sponsor: Apsen Farmaceutica S.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-19
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-26
• Study Start: 2023-01
• Primary Completion: 2025-01
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
APSLXR	APSLXR	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	during 60 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters in steady state	at Day 60	Cmáx_SS