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Latanoprost for the Treatment of Menière's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01973114
Recruitment Status : Active, not recruiting
First Posted : October 31, 2013
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
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 : October 2013
Estimated Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Latanoprost
U.S. FDA Resources

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 :
  1. Change in speech discrimination score in noise from Baseline [ Time Frame: 2 weeks ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973114


Locations
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
Karolinska Universitetssjukhuset
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
Västmanlands Sjukhus i Västerås
Västerås, Sweden
University Hospital Örebro
Örebro, Sweden
Sponsors and Collaborators
Synphora AB
Investigators
Principal Investigator: Mikael Karlberg, MD, PhD Lund University Hospital
More Information

Responsible Party: Synphora AB
ClinicalTrials.gov Identifier: NCT01973114     History of Changes
Other Study ID Numbers: M 05 - 2013
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016

Keywords provided by Synphora AB:
Menière's disease
Vertigo
Hearing loss
Tinnitus

Additional relevant MeSH terms:
Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Latanoprost
Antihypertensive Agents