Status:
WITHDRAWN
Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease
Lead Sponsor:
Apsen Farmaceutica S.A.
Conditions:
Meniere Disease
Vertigo
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Diagnosis of Meniere's Disease or Vertigo of Vestibular Origin;
- Voluntarily consent to participate in the study;
Exclusion
- Female patients who are pregnant or breastfeeding;
- Participants presenting uncontroled systolic hipertension (\>140/90 mmHg);
- Participants presenting uncontroled diabetes (blood glucose \>200 mg/dL).
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04674735
Start Date
January 1 2023
End Date
June 1 2025
Last Update
April 26 2022
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