Meniere's disease MedDRA version: 17.0 Level: PT Classification code 10027183 Term: Meniere's disease System Organ Class: 10013993 - Ear and labyrinth disorders
Conditions
Interventions
Product Name: OTO-104
Product Code: OTO-104
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: DEXAMETHASONE
CAS Number: 50-02-2
Concentration unit: mg milligram
Sponsors
Otonomy Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is a male or female aged 18 to 80 years, inclusive. 2. Subject has a diagnosis of definite unilateral Meniere’s disease by 1995 AAO-HNS criteria. 3. Subject agrees to maintain their current standard of care treatments for Meniere’s disease while on-study, including but not limited to low-salt diet, diuretic, and/or betahistine. 4. Female subjects of childbearing potential (i.e., not surgically sterile and/or not post-menopausal (=6 months since last menstrual period and 45 years of age or older)) must have a negative urine pregnancy test before randomization. Women of childbearing potential who are not abstinent from sex with male partners may be entered into the study if they are using and willing to continue to use adequate contraceptive precautions for the duration of the study (e.g., oral contraceptives, contraceptive implant or injection, intrauterine device, condom and spermicide, or diaphragm and spermicide). 5. Subject is willing to comply with the protocol and attend all study visits. 6. Subject is able to provide written informed consent, including agreement to specific privacy language either within the informed consent or in ancillary documents compliant with Data Protection Act in the United Kingdom before the initiation of any study-related procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Subject has an infection in the ear, sinuses, or upper respiratory system. 2. Subject is pregnant or lactating. 3. Subject has a history of immunodeficiency disease. 4. Subject has active or recent (<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma. 5. Subject has an abnormality of the tympanic membrane in the affected ear that would increase the risk associated with intratympanic injection including but not limited to a monomeric, atelectatic or atrophic tympanic membrane. 6. Subject has a history of tympanostomy tubes that includes evidence of perforation or lack of closure. 7. Subject has a history of previous endolymphatic sac surgery. 8. Subject has a history of previous use of intratympanic gentamicin in the affected ear. 9. Subject has history of drop attacks. 10. Subject has used systemic steroids within 1 month prior to screening. 11. Subject has had intratympanic steroids within 1 month prior to screening. 12. Subject has experienced an adverse reaction to intratympanic injection of steroids. 13. Subject has any other clinically significant illness or medical condition that, in the investigator’s and the medical monitor’s opinion, would prohibit the subject from participating in the study. 14. Subject has previously been randomized to a trial of OTO-104.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective in Part A is to evaluate the safety of two IT doses of 12 mg OTO-104 given at 3-month intervals in subjects with unilateral Meniere’s disease compared to placebo, while the Part B objective is to continue to assess the safety of two IT injections of 12 mg OTO-104 at 3-month intervals in an open-label phase.;Secondary Objective: Not applicable;Primary end point(s): • Adverse events • Audiometry assessments • Tympanometry • Local tolerability (otoscopic examinations);Timepoint(s) of evaluation of this end point: Adverse events - continuous from first injection The following are captured at Day 1, Month 3, Month 6, Month 12 - Audiometry assessments - Tympanometry - Local tolerability (otoscopic examinations) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical laboratory measurements Vital sign measurements Global vertigo, tinnitus, subjective hearing and aural fullness change questions at Visit 1 and at Months 3, 6, 9 and 12;Timepoint(s) of evaluation of this end point: The following are captured at Day 1, Month 3, Month 6, Month 12 • Clinical laboratory measurements • Vital sign measurements • Global vertigo, tinnitus, subjective hearing and aural fullness change | — |
Countries
United Kingdom
Contacts
Public ContactClinical Project Manager
CromSource
Outcome results
None listed