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

Vertigo Clinical Trial

Official 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04674735
• Other study ID #: APS004/2020
• Status: Withdrawn
• Phase: Phase 1
• Start date: January 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2022
• Source: Apsen Farmaceutica S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dizziness
• Meniere Disease
• Vertigo
• Vertigo Vestibular

Intervention

Drug:
• APSLXR
Oral coated tablets once a day for 60 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Apsen Farmaceutica S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events		during 60 days
Secondary	Pharmacokinetic parameters in steady state	Cmáx_SS	at Day 60