OTO-104 in Meniere's Disease
Research type
Research Study
Full title
A 6-MONTH, MULTICENTER, PHASE 3, OPEN-LABEL EXTENSION SAFETY STUDY OF OTO-104 GIVEN AT 3-MONTH INTERVALS BY INTRATYMPANIC INJECTION IN SUBJECTS WITH UNILATERAL MENIERE'S DISEASE
IRAS ID
207331
Contact name
John Phillips
Contact email
Sponsor organisation
Otonomy Inc
Eudract number
2016-000766-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 2 days
Research summary
This is a 6 month multicenter, Phase 3, Open-label extension safety study in participants with unilateral Meniere's disease. Participants will receive 1 Intratympanic (middle ear)of 12mg OTO-104 at 3 month intervals for a total of 2 injections. Safety data to be collected include adverse events, concomitant medications, otoscopy, vital signs, audiology, tympanometry, Columbia-Suicide Severity Scale (C-SSRS) questionnaire and a Meniere's disease symptom questionnaire.
Meniere's disease is a rare disorder that affects the inner ear. The objective of this study is to assess the safety of repeat IT (intratympanic)injections of 12mg OTO-104 at 3 month intervals in an open-label study in participants with unilateral Meniere's disease.
The study will be conducted at hospital sites; male and female participants are eligible who are aged 18 years or older.
The duration of the study for each participant will be a maximum of 6 months. Participants will be enrolled and will have up to two injections of OTO-104 at 3 month intervals. The study drug will be administered by an injection into the ear by inserting a needle through the eardrum. Before the injection, a small amount of lidocaine/prilocaine cream (a local anaesthetic) will be placed on the eardrum to reduce pain.
REC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0243
Date of REC Opinion
29 Jul 2016
REC opinion
Further Information Favourable Opinion