Efficacy and Safety of Isosorbide Oral Solution in Patients With Meniere's Disease

NCT06765993 | Not Yet Recruiting Phase 2

• 1 other identifier: BT-YSLC-001
• Study Type: interventional
• Target: 234
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of isosorbide oral solution compared with placebo in people with unilateral Meniere's disease. A total of approximately 234 subjects will be enrolled in this study: 72 subjects in phase Ⅱ and approximately 162 subjects in phase Ⅲ. Patients were randomly assigned to either the experimental group or the control group. The randomization ratios for phase Ⅱ and phase Ⅲ were 1:1 and 2:1, respectively.

Conditions

Meniere´s Disease

Keywords

Meniere´s disease; Attack; Hearing loss; Tinnitus; Isosorbide

Outcome Measures

Primary Outcomes (1)

• The changes from baseline in the number of vertigo attacks due to Meniere's disease during the treatment period

  3 months

Secondary Outcomes (7)

• The changes in the number of vertigo attacks caused by Meniere's disease compared with the baseline at 6 months after the first administration.

  6 months after the first administration

• The changes in the number of vertigo attacks caused by Meniere's disease compared with the baseline at 4-6 months after the first administration.

  4-6 months after the first administration

• The changes in hearing from baseline 6 months after the first dose.

  6 months after first dose

• Patient-reported outcomes (PRO) during the treatment period were assessed using the Dizziness Handicap Inventory (DHI).

  3 months after the first dose

• Patient-reported outcomes (PRO) during the treatment period were assessed using the Tinnitus Handicap Inventory (THI).

  3 months after the first dose

Other Outcomes (8)

• The incidence and level of adverse events (AEs), serious adverse events (SAEs), abnormal laboratory test indicators, etc.

  From the first dose to 30 days after the last dose

• Change in tinnitus severity from baseline at 6 months after first dosing.

  6 months after the first dose

• The change from baseline in the number of attacks due to Meniere's disease at 12 months after the first dose.

  at 12 months after the first administration

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: Isosorbide oral solution

Control group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Isosorbide oral solution DRUG

30 mL, TID

Experimental group

Placebo DRUG

30 mL, TID

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥18 and ≤65 years old.
• Patients with unilateral Meniere's disease who meet the diagnostic criteria for Meniere's disease in the Guidelines for the Diagnosis and Treatment of Meniere's Disease (2017).
• At least 3 episodes of vertigo caused by Meniere's disease within 6 months before enrollment.
• Those who understand and voluntarily sign the informed consent.

You may not qualify if:

• Patients who have had previous ear surgery for Meniere's disease.
• People who suffer from vertigo caused by organic lesions of the external, middle or inner ear.
• Patients with diseases that the investigators believe may limit the subjects' participation in this trial:
• patients with acute intracranial hematoma;
• patients with hypokalemia (serum potassium \< lower limit of normal) or severe dehydration (needing infusion, or hospitalization, or life-threatening, requiring emergency treatment);
• patients with acute pulmonary edema;
• patients with hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<60 mmHg during the screening period);
• patients with severe cardiovascular and cerebrovascular diseases: such as New York Heart Association grade III or IV heart failure, myocardial infarction or unstable angina pectoris within the last 6 months, severe heart failure, progressive multifocal leukoencephalopathy, hypertension that is difficult to control with drugs (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥100 mmHg), etc.;
• patients with major diseases of other important organs that affect their participation in this study.
• Patients who need to use diuretics other than trial drugs for a long time after enrollment.
• Patients with any of the following conditions are known or found in laboratory tests:
• serum creatinine (Cr) level is not within the normal range;
• human immunodeficiency virus (HIV) test is positive or has acquired immunodeficiency syndrome (AIDS);
• active syphilis infection (positive Treponema pallidum antibody and positive non-specific syphilis antibody);
• active hepatitis, hepatitis B: HBsAg and/or HBcAb are positive and HBV-DNA \> 500 IU/mL or the lower limit of detection of the research center \[only when the lower limit of detection of the research center is higher than 500 IU/mL\]; hepatitis C: HCV antibody is positive and HCV-RNA is positive or greater than the upper limit of normal value.

Sponsors & Collaborators

• Lunan Better Pharmaceutical Co., LTD.: lead

MeSH Terms

Conditions

Hearing Loss; Tinnitus

Interventions

Isosorbide

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Central Study Contacts

Weijia Kong, PhD

CONTACT

027-85726685; entwjkong@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 9, 2025
• Study Start: December 30, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share