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

This study is currently recruiting participants.

Verified by NeuroSystec Corporation, April 2010

First Received: August 10, 2009 Last Updated: April 20, 2010 History of Changes

Sponsor:	NeuroSystec Corporation
Information provided by:	NeuroSystec Corporation
ClinicalTrials.gov Identifier:	NCT00957788

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 I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled 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 ]

Estimated Enrollment:	24
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 0: Experimental	Drug: NST-001 Comparison of different dosages of drug.
Cohort 1: Experimental	Drug: NST-001 Comparison of different dosages of drug.
Cohort 2: Experimental	Drug: NST-001 Comparison of different dosages of drug.
Cohort 3: Experimental	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

Contacts

Contact: Randall Sanabria, MD	661-702-6880	rsanabria@neurosystec.com
Contact: Thomas Lobl, PhD	661-702-6880	tlobl@neurosystec.com

Locations

France, Cedex
Hôpital Avicenne	Recruiting
Bobigny, Cedex, France, 93009

Sponsors and Collaborators

NeuroSystec Corporation

Investigators

Principal Investigator:

Bruno Frachet, MD

Hôpital Avicenne

More Information

No publications provided

Responsible Party:	NeuroSystec Corporation ( Randall Sanabria - Director Clinical Projects )
ClinicalTrials.gov Identifier:	NCT00957788 History of Changes
Other Study ID Numbers:	NST-CP-02
Study First Received:	August 10, 2009
Last Updated:	April 20, 2010
Health Authority:	France: Afssaps - French Health Products Safety Agency; 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 September 02, 2010