Meniere DiseasePhase 1NCT04674735
Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease
A Phase 1 study testing APSLXR in people with Meniere Disease and Vertigo, run by Apsen Farmaceutica S.A..
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Meniere Disease, Vertigo, Vertigo Vestibular
- What is being tested?
- APSLXR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Meniere's Disease or Vertigo of Vestibular Origin;
- Voluntarily consent to participate in the study;
Who cannot join
- Female patients who are pregnant or breastfeeding;
- Participants presenting uncontroled systolic hipertension (>140/90 mmHg);
- Participants presenting uncontroled diabetes (blood glucose >200 mg/dL).
About this study
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
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.
- Conditions
- Meniere Disease, Vertigo, Vertigo Vestibular
- Being tested
- APSLXR
- Medical subject headings
- Meniere Disease, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APSLXRDrug
Oral coated tablets once a day for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| APSLXR | Experimental | Not described Receives: Drug: APSLXR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Measured: during 60 days
Secondary outcomes (1)
Pharmacokinetic parameters in steady state
Cmáx_SS
Measured: at Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study startJan 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJun 2025 (estimated)
Why it stopped: Cancelled by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniere DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apsen Farmaceutica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674735
- Sponsor's protocol ID
- APS004/2020
- Status last verified
- Apr 2022
- First submitted
- 8 Dec 2020
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04674735
- Acronym / sponsor ID
- APS004/2020
- Conditions
- Meniere Disease, Vertigo, Vertigo Vestibular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cancelled by Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Apsen Farmaceutica S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APSLXR | Experimental | Drug: APSLXR |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Meniere's Disease or Vertigo of Vestibular Origin;
- Voluntarily consent to participate in the study;
Key exclusion criteria (3 listed)
- Female patients who are pregnant or breastfeeding;
- Participants presenting uncontroled systolic hipertension (>140/90 mmHg);
- Participants presenting uncontroled diabetes (blood glucose >200 mg/dL).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APSLXROral coated tablets once a day for 60 days. | Drug | APSLXR |
Primary outcome
Incidence of Adverse Events
Time frame: during 60 days
1 secondary outcome
Pharmacokinetic parameters in steady state
Time frame: at Day 60
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APSLXR in people with Meniere Disease and Vertigo, run by Apsen Farmaceutica S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: during 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.