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

Tinnitus Clinical Trial

Official title:

Safety and Feasibility Study of NST - 001 in Inner Ear Using Neuroject Injection Set for the Treatment of Tinnitus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00957788
• Other study ID #: NST-CP-02
• Status: Terminated
• Phase: Phase 1
• First received: August 10, 2009
• Last updated: April 18, 2013
• Start date: January 2009
• Est. completion date: May 2013

Study information

• Verified date: June 2011
• Source: NeuroSystec Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Drug:
• NST-001
Comparison of different dosages of drug.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaries U.C.L.	Mont-Godinne
France	Hôpital Avicenne	Bobigny	Cedex

Sponsors (1)

Lead Sponsor	Collaborator
NeuroSystec Corporation

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects will be followed for identification and frequency of drug or procedure-related adverse events.		At each follow-up visit.	Yes
Secondary	Observe any effect on tinnitus as determined by the visual analog scale, subject tinnitus diary, and investigator interview.		At each follow-up visit.	No