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Completed

NCT Number: NCT02265393

A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom

This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United Kingdom. The first part is a randomized, placebo-controlled study comparing the safety profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an open-label extension where all subjects will receive an additional 2 intratympanic injections of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1 year.

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Key information

Conditions

Meniere's Disease Ear Diseases Endolymphatic Hydrops Labyrinth Diseases Meniere Disease Otorhinolaryngologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Heatherwood & Wexham Park Hospitals, Berkshire, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

includes, but is not limited to:

  • Subject has a diagnosis of definite unilateral Meniere's disease.
  • Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.

Exclusion criteria

includes, but is not limited to:

  • Subject is pregnant or lactating.
  • Subject has a history of immunodeficiency disease.
  • Subject has a history of previous endolymphatic sac surgery.
  • Subject has a history of previous use of intratympanic gentamicin in the affected ear.
  • Subject has a history of drop attacks.
  • Subject has experienced an adverse reaction to intratympanic injection of steroids.

Treatment and study plan

OTO-104

Drug

Placebo

Drug

Primary outcomes

  1. Safety

    Time frame: Up to 1 Year

    Otoscopy, audiometry, tympanometry, adverse events

Secondary outcomes

  1. Meniere's Symptom Questionnaire

    Time frame: Up to 1 Year

Sponsors and collaborators

Lead sponsor

Otonomy, Inc.

Industry

Registry information

Official study title

A 6-Month, Prospective, Randomized, Multicenter, Placebo-Controlled Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease Followed by a 6-Month Open-Label Extension

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 15, 2014
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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