Back to resultsSafety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease
Primary Purpose
Meniere Disease, Vertigo, Vertigo Vestibular
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
APSLXR
Sponsored by
About this trial
This is an interventional treatment trial for Meniere Disease
Eligibility 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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
APSLXR
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Adverse Events
Secondary Outcome Measures
Pharmacokinetic parameters in steady state
Cmáx_SS
Full Information
NCT ID
NCT04674735
First Posted
December 8, 2020
Last Updated
April 19, 2022
Sponsor
Apsen Farmaceutica S.A.
1. Study Identification
Unique Protocol Identification Number
NCT04674735
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Cancelled by Sponsor
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apsen Farmaceutica S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere Disease, Vertigo, Vertigo Vestibular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
APSLXR
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
APSLXR
Intervention Description
Oral coated tablets once a day for 60 days.
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Time Frame
during 60 days
Secondary Outcome Measure Information:
Title
Pharmacokinetic parameters in steady state
Description
Cmáx_SS
Time Frame
at Day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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).
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease
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