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The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTO-104 | Experimental | 12 mg dexamethasone |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTO-104 | Drug | Single intratympanic injection of 12 mg OTO-104 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3) | 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
| 3 months |
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Inclusion Criteria includes, but is not limited to:
Exclusion Criteria includes, but is not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Kathie Bishop, PhD | Otonomy, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many sites in US. Refer to the contact info listed below. | San Diego | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37185596 | Derived | 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. |
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In addition to meeting all screening visit inclusion criteria, potential subjects had to experience and record at least 4 and a maximum of 22 definitive vertigo day (DVD) during the 4 week lead-in period. In addition, the subject needed to complete at least 22 of 28 diary entries during the 4-week lead-in period. A DVD was defined each day the subject recorded a vertigo episode lasting at least 20 minutes corresponding to a vertigo score of 2 or more.
166 subjects were randomized and 165 subjects received study drug. The most common reason for screen failure was that there was not a sufficient number of definitive vertigo days in the 28-day lead-in period. The first subject enrolled on October 27, 2015, and the last subject completed the study on July 18, 2017. A total of 47 centers in the US enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | OTO-104 | 12 mg dexamethasone OTO-104: Single intratympanic injection of 12 mg OTO-104 |
| FG001 | Placebo | Placebo: Single intratympanic injection of placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OTO-104 (Full Analysis Set) | Subjects that were randomized to OTO-104, received study drug, had a baseline definitive vertigo measurement (i.e., at least 1 baseline daily diary entry) for the 4-week lead-in period and at least one 4-week definitive vertigo measurement post-baseline (i.e., at least 1 post baseline daily diary entry). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The full analysis set subjects who were randomized, received study drug, had a baseline definitive vertigo measurement for the 4-week lead-in period and at least one 4-week definitive vertigo measurement post-baseline, i.e., at least 1 post-baseline daily diary entry. | Posted | Least Squares Mean | 95% Confidence Interval | Definitive Vertigo Day | Week 12 (3 months) |
|
Reported or observed during or after dosing with the study drug at the Baseline visit up to the Week 12 (Month 3) end of study visit. The Baseline visit occurred after the Lead-in period when no intervention was administered. Therefore, collection of adverse events started during dosing at the Baseline visit and lasted to the end of the study (Week 12 (Month 3).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OTO-104 (Safety Analysis Set) | All subjects who received OTO-104. Subjects were included in this treatment group according to the actual treatment received regardless of their randomized assignment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney transplant rejection | Immune system disorders | MedDRA (18.1) | Non-systematic Assessment | The subject received a dose of study drug and 2 months later underwent a kidney transplant for end-stage renal disease secondary to diabetes after being on a 4-year waiting list. The rejection occurred 2 weeks after that and eventually resolved. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Otonomy Medical Information Center | Otonomy, Inc. | 1-844-686-4636 | medinfo@otonomy.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2016 | Sep 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008575 | Meniere Disease |
| D014717 | Vertigo |
| ID | Term |
|---|---|
| D018159 | Endolymphatic Hydrops |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Placebo |
| Drug |
Single intratympanic injection of placebo |
|
| Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3) | 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 (Week 12 [Month 3]). | 3 months |
| Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to 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 500 Hz. | 3 months |
| Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to 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. | Week 12 (Month 3) |
| Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to 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. | Week 12 (Month 3) |
| Did not receive study drug |
|
| BG001 |
| Placebo (Full Analysis Set) |
Subjects that were randomized to placebo, received study drug, had a baseline definitive vertigo measurement (i.e., at least 1 baseline daily diary entry) for the 4-week lead-in period and at least one 4-week definitive vertigo measurement post-baseline (i.e., at least 1 post baseline daily diary entry). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Previous IT Steroid Injection | Count of Participants | Participants |
|
| OG001 | Placebo (Full Analysis Set) | Subjects that were randomized to placebo, received study drug, had a baseline definitive vertigo measurement (i.e., at least 1 baseline daily diary entry) for the 4-week lead-in period and at least one 4-week definitive vertigo measurement post-baseline (i.e., at least 1 post baseline daily diary entry). |
|
|
|
| Secondary | Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3) | 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
| Posted | Mean | Standard Deviation | days | 3 months |
|
|
|
| Secondary | Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3) | 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 (Week 12 [Month 3]). | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to 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 500 Hz. | Subjects that had no impairment at the Baseline visit (air-bone gap <=10 dB) | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to 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. | Subjects that had no impairment at the Baseline visit (air-bone gap <=10 dB | Posted | Count of Participants | Participants | Week 12 (Month 3) |
|
|
|
| Secondary | Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to 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. | Subjects that had no impairment at the Baseline visit (air-bone gap <=10 dB) | Posted | Count of Participants | Participants | Week 12 (Month 3) |
|
|
|
| 0 |
| 82 |
| 2 |
| 82 |
| 34 |
| 82 |
| EG001 | Placebo (Safety Analysis Set) | All subjects who received Placebo. Subjects were included in this treatment group according to the actual treatment received regardless of their randomized assignment. | 0 | 83 | 2 | 83 | 30 | 83 |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hypoesthesia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
|
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| D015837 |
| Vestibular Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |