Menière's Disease Clinical Trial
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
| Verified date | March 2016 |
| Source | Synphora AB |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Medical Products Agency |
| Study type | Interventional |
The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost for the treatment of Menière's disease.
| Status | Active, not recruiting |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Falu Lasarett | Falun | |
| Sweden | Sahlgrenska Universitetssjukhuset | Göteborg | |
| Sweden | Blekinge Hospital | Karlskrona | |
| Sweden | Centralsjukhuset i Karlstad | Karlstad | |
| Sweden | Centralsjukhuset i Kristianstad | Kristianstad | |
| Sweden | Linköping University Hospital | Linköping | |
| Sweden | Sunderby Sjukhus | Luleå | |
| Sweden | Lund University Hospital | Lund | |
| Sweden | University Hospital Örebro | Örebro | |
| Sweden | Karolinska Universitetssjukhuset | Stockholm | |
| Sweden | Uppsala University Hospital | Uppsala | |
| Sweden | Västmanlands Sjukhus i Västerås | Västerås |
| Lead Sponsor | Collaborator |
|---|---|
| Synphora AB |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in speech discrimination score in noise from Baseline | 2 weeks | No | |
| Secondary | Change in speech discrimination score in noise from Baseline | 3 months | No | |
| Secondary | Change in pure tone audiometry from Baseline | 3 months | No | |
| Secondary | Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline | 3 months | No | |
| Secondary | Change in hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period | 3 months | No | |
| Secondary | Change in proportion of days with vertigo attacks from run-in period | 3 months | No | |
| Secondary | Comparison of number of drop attacks in each treatment arm | 3 months | No | |
| Secondary | Evaluation of adverse events and vital signs as measure of safety and tolerability | 3 months | Yes |