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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
NeuroSystec Corporation
ClinicalTrials.gov Identifier:
NCT00957788
First received: August 10, 2009
Last updated: April 18, 2013
Last verified: June 2011

August 10, 2009
April 18, 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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00957788 on ClinicalTrials.gov 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. ] [ Designated as safety issue: No ]
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
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Tinnitus
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France
 
NCT00957788
NST-CP-02
Yes
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