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FX-322 in Sensorineural Hearing Loss

2018-08-08 16:21:12 | BioPortfolio

Summary

This is a phase 1/2 single dose study of FX-322 compared to placebo in male and female adults otherwise healthy with stable sensorineural hearing loss.

Description

Sensorineural hearing loss (SNHL) accounts for about 90% of all cases of hearing loss. The study will assess the safety of FX-322 given as a single intratympanic injection in subjects with a medical history of sensorineural hearing loss that is associated with noise exposure or sudden hearing loss. Safety will be evaluated both systemically (lab and clinical monitoring) and locally (otoscopy and audiometry) in 24 subjects, and a blood PK profile of FX-322 will also be determined.

Study Design

Conditions

Sensorineural Hearing Loss

Intervention

FX-322, Placebo

Location

Worldwide Clinical Trials
San Antonio
Texas
United States
78217

Status

Recruiting

Source

Frequency Therapeutics

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-08-08T16:21:12-0400

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FX-322 in Adults With Stable Sensorineural Hearing Loss

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PubMed Articles [6153 Associated PubMed Articles listed on BioPortfolio]

Clinical Practice Guideline: Sudden Hearing Loss (Update).

Sudden hearing loss is a frightening symptom that often prompts an urgent or emergent visit to a health care provider. It is frequently but not universally accompanied by tinnitus and/or vertigo. Sudd...

Clinical Practice Guideline: Sudden Hearing Loss (Update) Executive Summary.

Sudden hearing loss is a frightening symptom that often prompts an urgent or emergent visit to a health care provider. It is frequently, but not universally, accompanied by tinnitus and/or vertigo. Su...

Open-angle glaucoma and sensorineural hearing impairment in the Korean population.

: This study identifies the prevalence and risk factors of sensorineural hearing loss and primary open-angle glaucoma (POAG).: Patients aged 19 years or older who had undergone both ophthalmologic exa...

Hearing Improvement after Sudden Sensorineural Hearing Loss as a Predictor of Vestibular Schwannoma.

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Acute profound sensorineural hearing loss as the initial manifestation of Hairy Cell Leukemia, Case Report and literature review.

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Medical and Biotech [MESH] Definitions

Hearing loss due to damage or impairment of both the conductive elements (HEARING LOSS, CONDUCTIVE) and the sensorineural elements (HEARING LOSS, SENSORINEURAL) of the ear.

Hearing loss resulting from damage to the COCHLEA and the sensorineural elements which lie internally beyond the oval and round windows. These elements include the AUDITORY NERVE and its connections in the BRAINSTEM.

Sensorineural hearing loss which develops suddenly over a period of hours or a few days. It varies in severity from mild to total deafness. Sudden deafness can be due to head trauma, vascular diseases, infections, or can appear without obvious cause or warning.

Hearing loss due to exposure to explosive loud noise or chronic exposure to sound level greater than 85 dB. The hearing loss is often in the frequency range 4000-6000 hertz.

Hearing loss due to disease of the AUDITORY PATHWAYS (in the CENTRAL NERVOUS SYSTEM) which originate in the COCHLEAR NUCLEI of the PONS and then ascend bilaterally to the MIDBRAIN, the THALAMUS, and then the AUDITORY CORTEX in the TEMPORAL LOBE. Bilateral lesions of the auditory pathways are usually required to cause central hearing loss. Cortical deafness refers to loss of hearing due to bilateral auditory cortex lesions. Unilateral BRAIN STEM lesions involving the cochlear nuclei may result in unilateral hearing loss.

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Hearing
Hearing, auditory perception, or audition is the ability to perceive sound by detecting vibrations, changes in the pressure of the surrounding medium through time, through an organ such as the ear. Sound may be heard through solid, liquid, or gaseous mat...

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