Safety Study for NST-001 and the Neuroject Injection Set to Treat Tinnitus
Safety and Feasibility Study of NST - 001 in Inner Ear Using Neuroject Injection Set for the Treatment of Tinnitus
1 other identifier
interventional
8
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2009
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 10, 2009
CompletedFirst Posted
Study publicly available on registry
August 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedApril 22, 2013
June 1, 2011
4.3 years
August 10, 2009
April 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjects will be followed for identification and frequency of drug or procedure-related adverse events.
At each follow-up visit.
Secondary Outcomes (1)
Observe any effect on tinnitus as determined by the visual analog scale, subject tinnitus diary, and investigator interview.
At each follow-up visit.
Study Arms (4)
Cohort 0
EXPERIMENTALCohort 1
EXPERIMENTALCohort 2
EXPERIMENTALCohort 3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cliniques Universitaries U.C.L.
Mont-Godinne, Belgium
Hôpital Avicenne
Bobigny, Cedex, 93009, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno Frachet, MD
Hôpital Avicenne
- STUDY DIRECTOR
Pierre Garin, MD
Cliniques Universitaries U.C.L.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2009
First Posted
August 12, 2009
Study Start
January 1, 2009
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
April 22, 2013
Record last verified: 2011-06