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

April 18, 2013 updated by: NeuroSystec Corporation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Mont-Godinne, Belgium
        • Cliniques Universitaries U.C.L.
  • France
    • Cedex
      • Bobigny, Cedex, France, 93009
        • Hopital Avicenne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Experimental: Cohort 0
Drug: NST-001
Comparison of different dosages of drug.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
At each follow-up visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroSystec Corporation

Investigators

  • Principal Investigator: Bruno Frachet, MD, Hopital Avicenne
  • Study Director: Pierre Garin, MD, Cliniques Universitaries U.C.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (Estimate)

August 12, 2009

Study Record Updates

Last Update Posted (Estimate)

April 22, 2013

Last Update Submitted That Met QC Criteria

April 18, 2013

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NST-CP-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tinnitus

Clinical Trials on NST-001

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe