A randomized, double-blind, placebo-controlled, parallel group study to determine the efficacy, the duration of action, and safety of latanoprost in patients with Menière’s disease

Phase 1

• Conditions: Menière´s disease; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2013-002261-18-SE
• Lead Sponsor: Synphora AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-24
• Last Update Posted: 27 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

? At least 18 years of age
? Definite unilateral Menière’s disease (AAO-HNS 1995)
? Disease stage II-IV: PTA4 (pure tone average at 4 frequencies, 0.5, 1.0, 2.0, and 3.0 kHz) > 25 dB (AAO-HNS 1995).
? Speech discrimination score in silence (using 50 Swedish PB words) no better than 85%. The signal level at the first measurement (Visit 1) is to be adjusted to each patient’s most comfortable level. This signal level is to be applied at the second measurement (Visit 2a/Day 1).
? At least three vertigo attacks (lasting = 20 minutes) during the three last months prior to inclusion
? Tinnitus during the last three months prior to inclusion
- Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

? Any medical or psychiatric condition, which could jeopardize or would compromise the subject’s ability to participate in this trial or decrease the likelihood of obtaining satisfactory data to achieve the objective of the trial e.g. dementia, alcohol or substance abuse
? Bilateral Menière’s disease
? Chronic otitis media on the ear affected by Menière’s disease
? Subjects not fluent in the Swedish language
? Bronchial asthma
? Previous intratympanic gentamicin or surgical therapy
? Previous intratympanic steroid therapy less than six months prior to inclusion
- Known hypersensitivity to local anesthetics
? Pregnant women
? Nursing women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to determine the efficacy and duration of action of latanoprost as treatment of Menière’s disease;Secondary Objective: The secondary objective is to determine the safety of latanoprost as a treatment of Menière’s disease.;Primary end point(s): Speech discrimination score in noise at Day 14;Timepoint(s) of evaluation of this end point: At day 14 after the first intratympanic injection of Latanopros/placebo

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ? Speech discrimination score in noise at Day 28, Day 42, Day 56 and Day 84<br>? Pure tone audiometry at 250Hz, 500Hz, 1kHz, 2 kHz, 3kHz, 4kHz, 6kHz, and 8 kHz<br>? Tinnitus (subjective assessment by THI)<br>? Hearing (subjective assessment by Likert scale) <br>? Tinnitus (subjective assessment by Likert scale) <br>? Vertigo (subjective assessment by Likert scale)<br>? Number of vertigo attacks lasting = 20 minutes (as recorded by patient)<br>? Number of drop attacks (as recorded by patient)<br>;Timepoint(s) of evaluation of this end point: At day 28, day 42, day 56 and day 84 after the first intratympanic injection of Latanoprost/placebo.