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

April 19, 2022 updated by: Apsen Farmaceutica S.A.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: APSLXR
Drug: APSLXR
Oral coated tablets once a day for 60 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events
Time Frame: during 60 days
during 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters in steady state
Time Frame: at Day 60
Cmáx_SS
at Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apsen Farmaceutica S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2023

Primary Completion (ANTICIPATED)

January 1, 2025

Study Completion (ANTICIPATED)

June 1, 2025

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (ACTUAL)

December 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APS004/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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