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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674735
Recruitment Status : Withdrawn (Cancelled by Sponsor)
First Posted : December 19, 2020
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
Apsen Farmaceutica S.A.

Tracking Information
First Submitted Date  ICMJE December 8, 2020
First Posted Date  ICMJE December 19, 2020
Last Update Posted Date April 26, 2022
Estimated Study Start Date  ICMJE January 2023
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2020)
Incidence of Adverse Events [ Time Frame: during 60 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2020)
Pharmacokinetic parameters in steady state [ Time Frame: at Day 60 ]
Cmáx_SS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Meniere Disease
  • Vertigo
  • Vertigo Vestibular
Intervention  ICMJE Drug: APSLXR
Oral coated tablets once a day for 60 days.
Study Arms  ICMJE Experimental: APSLXR
Intervention: Drug: APSLXR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 19, 2022)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2020)
150
Estimated Study Completion Date  ICMJE June 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04674735
Other Study ID Numbers  ICMJE APS004/2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Apsen Farmaceutica S.A.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Apsen Farmaceutica S.A.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Apsen Farmaceutica S.A.
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP