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

NeuroSystec

Status and phase: Terminated; Phase 1

Conditions: Tinnitus

Treatments: Drug: NST-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT00957788

NST-CP-02

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 4 patient groups

Cohort 0

Experimental group

Treatment:

Drug: NST-001

Cohort 1

Experimental group

Treatment:

Drug: NST-001

Cohort 2

Experimental group

Treatment:

Drug: NST-001

Cohort 3

Experimental group

Treatment:

Drug: NST-001