Safety Study for NST-001 and the Neuroject Injection Set to Treat Tinnitus
- Registration Number
- NCT00957788
- Lead Sponsor
- NeuroSystec Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 NST-001 - Cohort 0 NST-001 - Cohort 2 NST-001 - Cohort 3 NST-001 -
- Primary Outcome Measures
Name Time Method Subjects will be followed for identification and frequency of drug or procedure-related adverse events. At each follow-up visit.
- Secondary Outcome Measures
Name Time Method Observe any effect on tinnitus as determined by the visual analog scale, subject tinnitus diary, and investigator interview. At each follow-up visit.
Trial Locations
- Locations (2)
Cliniques Universitaries U.C.L.
🇧🇪Mont-Godinne, Belgium
Hôpital Avicenne
🇫🇷Bobigny, Cedex, France