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NCT04674735 Clinical Trial

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Clinical Trial Details — Status: Withdrawn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
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
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
Health authority
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Status Withdrawn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).

Study Design

Related Conditions & MeSH terms

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
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