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

Primary Purpose

Tinnitus

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
NST-001
Sponsored by
NeuroSystec Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, acouphenes, ear, ringing, buzzing, roaring, hissing, clicking

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cliniques Universitaries U.C.L.
  • Hôpital Avicenne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 0

Cohort 1

Cohort 2

Cohort 3

Arm Description

Outcomes

Primary Outcome Measures

Subjects will be followed for identification and frequency of drug or procedure-related adverse events.

Secondary Outcome Measures

Observe any effect on tinnitus as determined by the visual analog scale, subject tinnitus diary, and investigator interview.

Full Information

First Posted
August 10, 2009
Last Updated
April 18, 2013
Sponsor
NeuroSystec Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00957788
Brief Title
Safety Study for NST-001 and the Neuroject Injection Set to Treat Tinnitus
Official Title
Safety and Feasibility Study of NST - 001 in Inner Ear Using Neuroject Injection Set for the Treatment of Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroSystec Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus, acouphenes, ear, ringing, buzzing, roaring, hissing, clicking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 0
Arm Type
Experimental
Arm Title
Cohort 1
Arm Type
Experimental
Arm Title
Cohort 2
Arm Type
Experimental
Arm Title
Cohort 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NST-001
Intervention Description
Comparison of different dosages of drug.
Primary Outcome Measure Information:
Title
Subjects will be followed for identification and frequency of drug or procedure-related adverse events.
Time Frame
At each follow-up visit.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Frachet, MD
Organizational Affiliation
Hôpital Avicenne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Garin, MD
Organizational Affiliation
Cliniques Universitaries U.C.L.
Official's Role
Study Director
Facility Information:
Facility Name
Cliniques Universitaries U.C.L.
City
Mont-Godinne
Country
Belgium
Facility Name
Hôpital Avicenne
City
Bobigny
State/Province
Cedex
ZIP/Postal Code
93009
Country
France

12. IPD Sharing Statement

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

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