Trial | NCT00957788  Report issue

Title

Safety Study for NST-001 and the Neuroject Injection Set to Treat Tinnitus
Safety and Feasibility Study of NST - 001 in Inner Ear Using Neuroject Injection Set for the Treatment of Tinnitus

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    nst-001 ...

  • Study Participants

    8
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.
Study Started
Jan 31
2009
Primary Completion
May 31
2013
Anticipated
Study Completion
May 31
2013
Anticipated
Last Update
Apr 22
2013
Estimate

Drug NST-001

Comparison of different dosages of drug.

Cohort 0 Experimental

Cohort 1 Experimental

Cohort 2 Experimental

Cohort 3 Experimental

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.
No Results Posted