Safety of APSLXR in Patients Presenting Vertigo of Vestib... | NCT04674735

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

NCT04674735

Sponsor

Apsen Farmaceutica S.A.

Status

Withdrawn

Last Update Posted

Apr 26, 2022Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Meniere Disease
Vertigo
Vertigo Vestibular

Interventions

APSLXR

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Cancelled by Sponsor

Expanded Access Info

Start Date

Jan 2023Estimated

Primary Completion Date

Jan 2025Estimated

Completion Date

Jun 2025Estimated

First Submitted Date

Dec 8, 2020

First Submission Date that Met QC Criteria

Dec 14, 2020

First Posted Date

Dec 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2022

Last Update Posted Date

Apr 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
APSLXR	Experimental		Drug: APSLXR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
APSLXR	Drug	Oral coated tablets once a day for 60 days.	APSLXR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events		during 60 days

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic parameters in steady state	Cmáx_SS	at Day 60

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008575	Meniere Disease
D014717	Vertigo

Ancestor Terms

ID	Term
D018159	Endolymphatic Hydrops
D007759	Labyrinth Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided