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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00957788
Recruitment Status : Terminated
First Posted : August 12, 2009
Last Update Posted : April 22, 2013
Information provided by (Responsible Party):
NeuroSystec Corporation

August 10, 2009
August 12, 2009
April 22, 2013
January 2009
May 2013   (Final data collection date for primary outcome measure)
Subjects will be followed for identification and frequency of drug or procedure-related adverse events. [ Time Frame: At each follow-up visit. ]
Same as current
Complete list of historical versions of study NCT00957788 on Archive Site
Observe any effect on tinnitus as determined by the visual analog scale, subject tinnitus diary, and investigator interview. [ Time Frame: At each follow-up visit. ]
Same as current
Not Provided
Not Provided
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
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.
Not Provided
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: NST-001
Comparison of different dosages of drug.
  • Experimental: Cohort 0
    Intervention: Drug: NST-001
  • Experimental: Cohort 1
    Intervention: Drug: NST-001
  • Experimental: Cohort 2
    Intervention: Drug: NST-001
  • Experimental: Cohort 3
    Intervention: Drug: NST-001
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2013
May 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Belgium,   France
Not Provided
Not Provided
NeuroSystec Corporation
NeuroSystec Corporation
Not Provided
Principal Investigator: Bruno Frachet, MD Hôpital Avicenne
Study Director: Pierre Garin, MD Cliniques Universitaries U.C.L.
NeuroSystec Corporation
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP