Status:
TERMINATED
Safety Study for NST-001 and the Neuroject Injection Set to Treat Tinnitus
Lead Sponsor:
NeuroSystec Corporation
Conditions:
Tinnitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00957788
Start Date
January 1 2009
End Date
May 1 2013
Last Update
April 22 2013
Active Locations (2)
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1
Cliniques Universitaries U.C.L.
Mont-Godinne, Belgium
2
Hôpital Avicenne
Bobigny, Cedex, France, 93009