Safety Study for NST-001 and the Neuroject Injection Set to Treat Tinnitus

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeuroSystec Corporation

Criteria

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.