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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.
ClinicalTrials.gov Identifier: NCT00957788
Recruitment Status : Terminated
First Posted : August 12, 2009
Last Update Posted : April 22, 2013
Information provided by (Responsible Party):
NeuroSystec Corporation

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 for the treatment of tinnitus.

Condition or disease Intervention/treatment Phase
Tinnitus Drug: NST-001 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility Study of NST - 001 in Inner Ear Using Neuroject Injection Set for the Treatment of Tinnitus
Study Start Date : January 2009
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cohort 0 Drug: NST-001
Comparison of different dosages of drug.
Experimental: Cohort 1 Drug: NST-001
Comparison of different dosages of drug.
Experimental: Cohort 2 Drug: NST-001
Comparison of different dosages of drug.
Experimental: Cohort 3 Drug: NST-001
Comparison of different dosages of drug.

Primary Outcome Measures :
  1. Subjects will be followed for identification and frequency of drug or procedure-related adverse events. [ Time Frame: At each follow-up visit. ]

Secondary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957788

Cliniques Universitaries U.C.L.
Mont-Godinne, Belgium
Hôpital Avicenne
Bobigny, Cedex, France, 93009
Sponsors and Collaborators
NeuroSystec Corporation
Principal Investigator: Bruno Frachet, MD Hôpital Avicenne
Study Director: Pierre Garin, MD Cliniques Universitaries U.C.L.

Responsible Party: NeuroSystec Corporation
ClinicalTrials.gov Identifier: NCT00957788     History of Changes
Other Study ID Numbers: NST-CP-02
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: April 22, 2013
Last Verified: June 2011

Keywords provided by NeuroSystec Corporation:

Additional relevant MeSH terms:
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms