TinnitusPhase 1NCT00957788
Safety Study for NST-001 and the Neuroject Injection Set to Treat Tinnitus
A Phase 1 study testing NST-001 in people with Tinnitus, run by NeuroSystec Corporation at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- NST-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2009to May 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
- Conditions
- Tinnitus
- Being tested
- NST-001
- Keywords
- tinnitus, acouphenes, ear, ringing, buzzing, roaring, hissing, clicking
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NST-001Drug
Comparison of different dosages of drug.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 0 | Experimental | Not described Receives: Drug: NST-001 |
| Cohort 1 | Experimental | Not described Receives: Drug: NST-001 |
| Cohort 2 | Experimental | Not described Receives: Drug: NST-001 |
| Cohort 3 | Experimental | Not described Receives: Drug: NST-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects will be followed for identification and frequency of drug or procedure-related adverse events.
Measured: 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.
Measured: At each follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroSystec Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruno Frachet, MD, Principal investigator, Hôpital AvicennePierre Garin, MD, Study director, Cliniques Universitaries U.C.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957788
- Sponsor's protocol ID
- NST-CP-02
- Status last verified
- Jun 2011
- First submitted
- 10 Aug 2009
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Study of NST - 001 in Inner Ear Using Neuroject Injection Set for the Treatment of Tinnitus
- ClinicalTrials.gov ID
- NCT00957788
- Acronym / sponsor ID
- NST-CP-02
- Conditions
- Tinnitus
- Keywords
- tinnitus, acouphenes, ear, ringing, buzzing, roaring, hissing, clicking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NeuroSystec CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 12 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 0 | Experimental | Drug: NST-001 |
| Cohort 1 | Experimental | Drug: NST-001 |
| Cohort 2 | Experimental | Drug: NST-001 |
| Cohort 3 | Experimental | Drug: NST-001 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NST-001Comparison of different dosages of drug. | Drug | Cohort 0, Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Subjects will be followed for identification and frequency of drug or procedure-related adverse events.
Time frame: At each follow-up visit.
1 secondary outcome
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Frachet, MD principal investigator
Hôpital Avicenne
Pierre Garin, MD study director
Cliniques Universitaries U.C.L.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NST-001 in people with Tinnitus, run by NeuroSystec Corporation at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects will be followed for identification and frequency of drug or procedure-related adverse events. (time frame: At each follow-up visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013.