NCT04674735

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2023

Typical duration for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

December 8, 2020

Last Update Submit

April 19, 2022

Conditions

Meniere DiseaseVertigoVertigo Vestibular

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events

    during 60 days

Secondary Outcomes (1)

  • Pharmacokinetic parameters in steady state

    at Day 60

Study Arms (1)

APSLXR

EXPERIMENTAL
Drug: APSLXR

Interventions

APSLXRDRUG

Oral coated tablets once a day for 60 days.

APSLXR

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Female patients who are pregnant or breastfeeding;
  • Participants presenting uncontroled systolic hipertension (\>140/90 mmHg);
  • Participants presenting uncontroled diabetes (blood glucose \>200 mg/dL).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Meniere DiseaseVertigo

Condition Hierarchy (Ancestors)

Endolymphatic HydropsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesVestibular DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 19, 2020

Study Start

January 1, 2023

Primary Completion

January 1, 2025

Study Completion

June 1, 2025

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share