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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674735
Recruitment Status : Not yet recruiting
First Posted : December 19, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Apsen Farmaceutica S.A.

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.

Condition or disease Intervention/treatment Phase
Meniere Disease Vertigo Vertigo Vestibular Drug: APSLXR Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: APSLXR Drug: APSLXR
Oral coated tablets once a day for 60 days.




Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: during 60 days ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters in steady state [ Time Frame: at Day 60 ]
    Cmáx_SS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674735


Contacts
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Contact: Fernanda Martinez, B.Sc. +551156448200 ext 8404 fernanda.martinez@apsen.com.br

Sponsors and Collaborators
Apsen Farmaceutica S.A.
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Responsible Party: Apsen Farmaceutica S.A.
ClinicalTrials.gov Identifier: NCT04674735    
Other Study ID Numbers: APS004/2020
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vertigo
Meniere Disease
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Sensation Disorders
Endolymphatic Hydrops