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Latanoprost for the Treatment of Menière's Disease

Primary Purpose

Menière's Disease

Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Latanoprost
Placebo
Sponsored by
Synphora AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menière's Disease focused on measuring Menière's disease, Vertigo, Hearing loss, Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Falu Lasarett
  • Sahlgrenska Universitetssjukhuset
  • Blekinge Hospital
  • Centralsjukhuset i Karlstad
  • Centralsjukhuset i Kristianstad
  • Linköping University Hospital
  • Sunderby Sjukhus
  • Lund University Hospital
  • Karolinska Universitetssjukhuset
  • Uppsala University Hospital
  • Västmanlands Sjukhus i Västerås
  • University Hospital Örebro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

One intratympanic injection of latanoprost (Day1)

One intratympanic injection of placebo

Three intratympanic injections of latanoprost (Day 1, 2 and 3)

Three intratympanic injections of placebo (Day 1, 2 and 3)

Outcomes

Primary Outcome Measures

Change in speech discrimination score in noise from Baseline

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2013
Last Updated
March 22, 2016
Sponsor
Synphora AB
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1. Study Identification

Unique Protocol Identification Number
NCT01973114
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synphora AB

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menière's Disease
Keywords
Menière's disease, Vertigo, Hearing loss, Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
One intratympanic injection of latanoprost (Day1)
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
One intratympanic injection of placebo
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Three intratympanic injections of latanoprost (Day 1, 2 and 3)
Arm Title
Group 4
Arm Type
Placebo Comparator
Arm Description
Three intratympanic injections of placebo (Day 1, 2 and 3)
Intervention Type
Drug
Intervention Name(s)
Latanoprost
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in speech discrimination score in noise from Baseline
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change in speech discrimination score in noise from Baseline
Time Frame
3 months
Title
Change in pure tone audiometry from Baseline
Time Frame
3 months
Title
Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline
Time Frame
3 months
Title
Change in hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period
Time Frame
3 months
Title
Change in proportion of days with vertigo attacks from run-in period
Time Frame
3 months
Title
Comparison of number of drop attacks in each treatment arm
Time Frame
3 months
Title
Evaluation of adverse events and vital signs as measure of safety and tolerability
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikael Karlberg, MD, PhD
Organizational Affiliation
Lund University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Falu Lasarett
City
Falun
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
Country
Sweden
Facility Name
Blekinge Hospital
City
Karlskrona
Country
Sweden
Facility Name
Centralsjukhuset i Karlstad
City
Karlstad
Country
Sweden
Facility Name
Centralsjukhuset i Kristianstad
City
Kristianstad
Country
Sweden
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Facility Name
Sunderby Sjukhus
City
Luleå
Country
Sweden
Facility Name
Lund University Hospital
City
Lund
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
Facility Name
Västmanlands Sjukhus i Västerås
City
Västerås
Country
Sweden
Facility Name
University Hospital Örebro
City
Örebro
Country
Sweden

12. IPD Sharing Statement

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Latanoprost for the Treatment of Menière's Disease

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