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

Phase 3

Terminated

• Conditions: Meniere's Disease
• Interventions: Drug: Placebo; Drug: OTO-104

• Registration Number: NCT02717442
• Lead Sponsor: Otonomy, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-17
• Study Start: 2016-03-21
• Study First Posted: 2016-03-23
• Primary Completion: 2017-08-31
• Study Completion: 2017-09-15
• Results First Submitted: 2022-10-24
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-19
• Last Update Submitted: 2022-12-19
• Results First Posted: 2023-01-13
• Last Update Posted: 2023-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
OTO-104	OTO-104	12 mg dexamethasone

Primary Outcome Measures

Name	Time	Method
The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-2 Population	3 months	The number of DVDs at Week 12 (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. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.
The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-1 Population	3 months	In the Full Analysis Set (FAS)-1 population, the number of DVDs at Week 12 (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. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.

Secondary Outcome Measures

Name	Time	Method
Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3)	3 months	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. Week 12 (Month 3) = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.
Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-1	3 months	Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.; Questionnaire - subjects were instructed to record the effect on their daily activities of their total vertigo experienced that day using a 5-point scoring system: 0 = normal activity; 1. = slight limitation; 2. = moderate limitation; 3. = sick at home; 4. = bedridden
Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)	3 months	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. Week 12 (Month 3) = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.
Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-2	3 months	Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.; Questionnaire - subjects were instructed to record the effect on their daily activities of their total vertigo experienced that day using a 5-point scoring system: 0 = normal activity; 1. = slight limitation; 2. = moderate limitation; 3. = sick at home; 4. = bedridden
Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3)	3 months	Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection at the Baseline visit persisted at the end of study visit (Week12 \[Month 3\]). Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.
Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to Week 12 (Month 3)	3 Months	The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment (\<=10 dB) to impairment (\>10 dB) when measure at 500 Hz. Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.

Trial Locations

Locations (1)

Many sites in Europe. Refer to the contact info listed below.; 🇺🇸 San Diego, California, United States