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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014