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Completed

NCT Number: NCT03664674

Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease

The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

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Key information

Conditions

Meniere Disease Ear Diseases Endolymphatic Hydrops Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department, Edegem, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
  • Subject has experienced active vertigo during the lead-in period.
  • Subject has documented asymmetric sensorineural hearing loss.
  • Subject agrees to maintain their current treatments for Meniere's disease while on-study.

Exclusion criteria

  • Subject is pregnant or lactating.
  • Subject has a history of immunodeficiency disease.
  • Subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear.
  • Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
  • Subject has a history of vestibular migraine.
  • Subject has used an investigational drug or device in the 3 months prior to screening.
  • Subject has previously been randomized to a clinical study of OTO-104.

Treatment and study plan

OTO-104

Drug

Single intratympanic injection of 12 mg dexamethasone

Placebo

Drug

Single intratympanic injection of placebo

Primary outcomes

  1. 28-Day Average DVD at Week 12 (Month 3)

    Time frame: 3 months

    The count of definitive vertigo days for Week 12 was determined during the 4-week period between Weeks 9 and 12. The 28-day average DVD was derived for each subject and visit by summing each subject's number of DVD counts within the 4-week interval, dividing by the number of completed diary days, and multiplying by 28.

Secondary outcomes

  1. Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden

    Time frame: 3 Months

    The count of days sick at home or bedridden for subsequent intervals was determined during the 4-week period between each visit. The count of days sick at home or bedridden was computed as the sum of the days in the Sick at home and Bedridden categories for each 4-week interval and was standardized to 28 days by multiplying by 28 days and dividing by the number of non-missing diary entries.

  2. Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit

    Time frame: 3 months

    Ear examinations were done at every visit. One of the important safety endpoints was an observation of a perforation in the ear drum did not heal properly after the injection. Reported here are the Week 12 (Month 3) final visit.

  3. Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3)

    Time frame: Week 12 (Month 3)

    The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 1000 Hz.

  4. Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)

    Time frame: Week 12 (Month 3)

    The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 2000 Hz.

  5. Audiometry - Shift in Air-Bone Gap at 4000 Hz From Baseline to Week 12 (Month 3)

    Time frame: Week 12 (Month 3)

    The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 4000 Hz.

Sponsors and collaborators

Lead sponsor

Otonomy, Inc.

Industry

Registry information

Official study title

A Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2018
Registry last updated
Dec 7, 2022

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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