Safety Study for NST-001 and the Neuroject Injection Set... | NCT00957788

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

NCT00957788

Sponsor

NeuroSystec Corporation

Status

Terminated

Last Update Posted

Apr 22, 2013Estimated

Enrollment

8Actual

Phase

Phase 1

Conditions

Tinnitus

Interventions

NST-001

Countries

Belgium
France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

May 2013Estimated

Completion Date

May 2013Estimated

First Submitted Date

Aug 10, 2009

First Submission Date that Met QC Criteria

Aug 10, 2009

First Posted Date

Aug 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2013

Last Update Posted Date

Apr 22, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Cohort 0	Experimental	Drug: NST-001
Cohort 1	Experimental	Drug: NST-001
Cohort 2	Experimental	Drug: NST-001
Cohort 3	Experimental	Drug: NST-001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NST-001	Drug	Comparison of different dosages of drug.	Cohort 0 Cohort 1 Cohort 2 Cohort 3

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Observe any effect on tinnitus as determined by the visual analog scale, subject tinnitus diary, and investigator interview.		At each follow-up visit.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruno Frachet, MD	Hôpital Avicenne	Principal Investigator
Pierre Garin, MD	Cliniques Universitaries U.C.L.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques Universitaries U.C.L.		Mont-Godinne			Belgium
Hôpital Avicenne

Condition Browse Module

MeSH Terms

ID	Term
D014012	Tinnitus

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided