Tinnitus
Conditions
Keywords
tinnitus, acouphenes, ear, ringing, buzzing, roaring, hissing, clicking
Brief summary
This research study involves an experimental drug (NST\_001) and a delivery system. The main purpose of this research study is to investigate the safety of NST-001, delivered directly to the inner ear for the treatment of tinnitus.
Interventions
DRUGNST-001
Comparison of different dosages of drug.
Sponsors
NeuroSystec Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients able to provide voluntary consent. * Severe tinnitus in one ear that began no more than ten years ago. * Ear to be treated must be deaf or have profound hearing loss. * Subjects with cardiac disease or hypertension, must have stable disease for at least 6 months. * Subject must have intact cochlear nerve on the ear to be treated. * Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods as recommended by the study physician.
Exclusion criteria
* Current diagnosis of bilateral tinnitus. * Current diagnosis or history of pancreatitis. * Females that are pregnant or lactating. * Use of investigational drugs within the previous 30 days. * History of drug dependency or other substance abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjects will be followed for identification and frequency of drug or procedure-related adverse events. | At each follow-up visit. |
Secondary
| Measure | Time frame |
|---|---|
| Observe any effect on tinnitus as determined by the visual analog scale, subject tinnitus diary, and investigator interview. | At each follow-up visit. |
Countries
Belgium, France
Outcome results
None listed