Latanoprost for the Treatment of Menière's Disease

Sponsor

Synphora AB (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01973114

Collaborator

(none)

100

Enrollment

Locations

Arms

8.3

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menière's Disease	Drug: Latanoprost Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 One intratympanic injection of latanoprost (Day1)	Drug: Latanoprost
Placebo Comparator: Group 2 One intratympanic injection of placebo	Other: Placebo
Experimental: Group 3 Three intratympanic injections of latanoprost (Day 1, 2 and 3)	Drug: Latanoprost
Placebo Comparator: Group 4 Three intratympanic injections of placebo (Day 1, 2 and 3)	Other: Placebo

Outcome Measures

Primary Outcome Measures

Change in speech discrimination score in noise from Baseline [2 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Falu Lasarett	Falun	Sweden
2	Sahlgrenska Universitetssjukhuset	Göteborg	Sweden
3	Blekinge Hospital	Karlskrona	Sweden
4	Centralsjukhuset i Karlstad	Karlstad	Sweden
5	Centralsjukhuset i Kristianstad	Kristianstad	Sweden
6	Linköping University Hospital	Linköping	Sweden
7	Sunderby Sjukhus	Luleå	Sweden
8	Lund University Hospital	Lund	Sweden
9	Karolinska Universitetssjukhuset	Stockholm	Sweden
10	Uppsala University Hospital	Uppsala	Sweden
11	Västmanlands Sjukhus i Västerås	Västerås	Sweden
12	University Hospital Örebro	Örebro	Sweden