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

NCT02612337 | Completed Phase 3 Results

• 1 other identifier: 104-201506
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Meniere's Disease

Keywords

Meniere's Disease; Vertigo

Outcome Measures

Primary Outcomes (1)

• The Number of DVD at Week 12 (Defined as the 4-week [28 Days] Interval From Week 9 Through Week 12).

  The number of DVDs at Week 12 (defined as the 4-week \[28 days\] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. Baseline occurred at the end of lead-in and no intervention was administered during lead-in.

  Week 12 (3 months)

Secondary Outcomes (5)

• Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3)

  3 months

• Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3)

  3 months

• Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to Week 12 (Month 3)

  3 months

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

  Week 12 (Month 3)

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

  Week 12 (Month 3)

Study Arms (2)

OTO-104

EXPERIMENTAL

12 mg dexamethasone

Drug: OTO-104

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

OTO-104 DRUG

Single intratympanic injection of 12 mg OTO-104

OTO-104

Placebo DRUG

Single intratympanic injection of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 (IT) gentamicin in the affected ear.
• Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
• Subject has experienced an adverse reaction to IT injection of steroids.
• Subject has used an investigational drug or device in the 3 months prior to screening.
• Subject has previously been randomized to a trial of OTO-104.

Sponsors & Collaborators

• Otonomy, Inc.: lead

Study Sites (1)

Many sites in US. Refer to the contact info listed below.

San Diego, California, United States

Location

Related Publications (1)

• Phillips J, Mikulec AA, Robinson JM, Skarinsky D, Anderson JJ. Efficacy of Intratympanic OTO-104 for the Treatment of Meniere's Disease: The Outcome of Three Randomized, Double-Blind, Placebo-Controlled Studies. Otol Neurotol. 2023 Jul 1;44(6):584-592. doi: 10.1097/MAO.0000000000003886. Epub 2023 Apr 22.

  PMID: 37185596 DERIVED

MeSH Terms

Conditions

Meniere Disease; Vertigo

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Otonomy Medical Information Center
• Organization: Otonomy, Inc.

medinfo@otonomy.com

1-844-686-4636

Study Officials

• Kathie Bishop, PhD

  Otonomy, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 23, 2015
• Study Start: October 27, 2015
• Primary Completion: July 18, 2017
• Study Completion: July 18, 2017
• Last Updated: January 12, 2023
• Results First Posted: January 12, 2023

Record last verified: 2022-12

Locations

US (1)