Latanoprost for the Treatment of Menière's Disease

Phase 2

• Conditions: Menière's Disease
• Interventions: Other: Placebo; Drug: Latanoprost

• Registration Number: NCT01973114
• Lead Sponsor: Synphora AB

Brief Summary

The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost for the treatment of Menière's disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-31
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-23
• Primary Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• At least 18 years of age
• Definitive unilateral Menière's disease (AAO-HNS 1995)
• Disease stage II - III: PTA4 (Pure Tone Average) (0.5, 1.0, 2.0 and 3.0kHz) between 25dB and 70dB
• Speech discrimination score in silence: No better than 85%
• At least three vertigo attacks (lasting ≥ 20 minutes) during the last three months prior to inclusion
• Tinnitus during the last three months prior to inclusion
• Signed written informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Placebo	One intratympanic injection of placebo
Group 4	Placebo	Three intratympanic injections of placebo (Day 1, 2 and 3)
Group 1	Latanoprost	One intratympanic injection of latanoprost (Day1)
Group 3	Latanoprost	Three intratympanic injections of latanoprost (Day 1, 2 and 3)

Primary Outcome Measures

Name	Time	Method
Change in speech discrimination score in noise from Baseline	2 weeks

Secondary Outcome Measures

Name	Time	Method
Change in proportion of days with vertigo attacks from run-in period	3 months
Change in pure tone audiometry from Baseline	3 months
Change in speech discrimination score in noise from Baseline	3 months
Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline	3 months
Evaluation of adverse events and vital signs as measure of safety and tolerability	3 months
Change in hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period	3 months
Comparison of number of drop attacks in each treatment arm	3 months

Trial Locations

Locations (12)

Sunderby Sjukhus; 🇸🇪 Luleå, Sweden

Falu Lasarett; 🇸🇪 Falun, Sweden

Centralsjukhuset i Karlstad; 🇸🇪 Karlstad, Sweden

Karolinska Universitetssjukhuset; 🇸🇪 Stockholm, Sweden

Sahlgrenska Universitetssjukhuset; 🇸🇪 Göteborg, Sweden

Blekinge Hospital; 🇸🇪 Karlskrona, Sweden

Centralsjukhuset i Kristianstad; 🇸🇪 Kristianstad, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Västmanlands Sjukhus i Västerås; 🇸🇪 Västerås, Sweden

University Hospital Örebro; 🇸🇪 Örebro, Sweden

Linköping University Hospital; 🇸🇪 Linköping, Sweden

Lund University Hospital; 🇸🇪 Lund, Sweden