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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
History of Changes
  Purpose

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 Intervention Phase
Tinnitus
 Drug: NST-001
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Further study details as provided by NeuroSystec Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: January 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957788

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

No publications provided

Responsible Party: NeuroSystec Corporation
ClinicalTrials.gov Identifier: NCT00957788     History of Changes
Other Study ID Numbers: NST-CP-02
Study First Received: August 10, 2009
Last Updated: April 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by NeuroSystec Corporation:
tinnitus
acouphenes
ear
ringing
 buzzing
roaring
hissing
clicking

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

ClinicalTrials.gov processed this record on May 23, 2013