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WithdrawnNCT04674735Updated Sep 8, 2026

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

A Phase 1 interventional study of APSLXR in Meniere Disease, Vertigo and Vertigo Vestibular, sponsored by Apsen Farmaceutica S.A.. Withdrawn. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Apsen Farmaceutica S.A. · Phase 1, Interventional, and Treatment

Why this study was withdrawn
Cancelled by Sponsor
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Meniere Disease
  • Vertigo
  • Vertigo Vestibular
03

In context

Meniere Disease

74 studies on the registry are indexed under Meniere Disease; 12 are open to participants now.

Browse Meniere Disease studies →

Lead sponsor

Apsen Farmaceutica S.A. is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of Meniere's Disease or Vertigo of Vestibular Origin;
  • Voluntarily consent to participate in the study;

Exclusion criteria

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).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    APSLXR

    Drug: APSLXR

Interventions

  • DrugAPSLXR

    Oral coated tablets once a day for 60 days.

06

What researchers measure

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: during 60 days

Secondary outcomes

  1. Pharmacokinetic parameters in steady state

    Cmáx\_SS

    Time frame: at Day 60

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2023; primary completion for Jan 2025, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2020
First posted
Dec 19, 2020
StartEst.
Jan 2023
Primary completionEst.
Jan 2025
CompletionEst.
Jun 2025
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04674735
Lead sponsor
Apsen Farmaceutica S.A.
Responsible party
Sponsor
First posted
Dec 19, 2020
Start date
Jan 2023 (estimated)
Primary completion
Jan 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Sep 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Apsen Farmaceutica S.A.

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