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History of Changes for Study: NCT04674735
Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease
Latest version (submitted April 19, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 14, 2020 None (earliest Version on record)
2 April 19, 2022 Recruitment Status, Study Status, Study Design, Contacts/Locations and Oversight
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Study NCT04674735
Submitted Date:  December 14, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: APS004/2020
Brief Title: Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease
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
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2020
Overall Status: Not yet recruiting
Study Start: July 2021
Primary Completion: September 2022 [Anticipated]
Study Completion: October 2022 [Anticipated]
First Submitted: December 8, 2020
First Submitted that
Met QC Criteria:
December 14, 2020
First Posted: December 19, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
December 14, 2020
Last Update Posted: December 19, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Apsen Farmaceutica S.A.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Meniere Disease
Vertigo
Vertigo Vestibular
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 150 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: APSLXR Drug: APSLXR
Oral coated tablets once a day for 60 days.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of Adverse Events
[ Time Frame: during 60 days ]

Secondary Outcome Measures:
1. Pharmacokinetic parameters in steady state
[ Time Frame: at Day 60 ]

Cmáx_SS
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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).
Open or close this module Contacts/Locations
Central Contact Person: Fernanda Martinez, B.Sc.
Telephone: +551156448200 Ext. 8404
Email: fernanda.martinez@apsen.com.br
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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