Clinical trial NCT01973114: Latanoprost for the Treatment of Menière's Disease
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Menière's Disease
Keywords: Menière's disease
Vertigo
Hearing loss
Tinnitus
Lead sponsor: Synphora AB
Sponsor class: INDUSTRY
First posted: 2013-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in speech discrimination score in noise from Baseline
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in speech discrimination score in noise from Baseline
timeFrame: 3 months
measure: Change in pure tone audiometry from Baseline
timeFrame: 3 months
measure: Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline
timeFrame: 3 months
measure: Change in hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period
timeFrame: 3 months
measure: Change in proportion of days with vertigo attacks from run-in period
timeFrame: 3 months
measure: Comparison of number of drop attacks in each treatment arm
timeFrame: 3 months
measure: Evaluation of adverse events and vital signs as measure of safety and tolerability
timeFrame: 3 months
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Falu Lasarett
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Karlskrona
country: Sweden
facility: Blekinge Hospital
city: Karlstad
country: Sweden
facility: Centralsjukhuset i Karlstad
city: Kristianstad
country: Sweden
facility: Centralsjukhuset i Kristianstad
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Luleå
country: Sweden
facility: Sunderby Sjukhus
city: Lund
country: Sweden
facility: Lund University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Västerås
country: Sweden
facility: Västmanlands Sjukhus i Västerås
city: Örebro
country: Sweden
facility: University Hospital Örebro
Study officials:
affiliation: Lund University Hospital
name: Mikael Karlberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: