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Hearing Loss Treatment Report

www.HearingLossTreatmentReport.com

Phase 2

A Phase 1b/​2a, Study Evaluating the Safety, PK/​PD and Efficacy of NS101 in SSNHL Patients

February 8, 2024

https://clinicaltrials.gov/study/NCT06249919

A Phase 1b/​2a, Study Evaluating the Safety, PK/​PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients

FX-322 in Adults With Acquired Sensorineural Hearing Loss

October 20, 2021

CATEGORY:
Clinical Trials

TITLE:
FX-322 in Adults With Acquired Sensorineural Hearing Loss

INTERVENTION/TREATMENT:

PHASE:

DESCRIPTION:
Conditions :   Hearing Loss, Sensorineural;   Noise Induced Hearing Loss;   Sudden Hearing Loss

Interventions :   Drug: FX-322;   Drug: Placebo

Sponsor :   Frequency Therapeutics

Recruiting

ID:
NCT05086276

STATUS:

DATE – FIRST POSTED:
Wed, 20 Oct 2021 12:00:00 EDT

DATE – LAST UPDATE POSTED:
10/20/21 06:28AM

DATE – RETRIEVED:
10/20/21 06:28AM

LINK – STUDY HISTORY:
https://clinicaltrials.gov/ct2/history/NCT05086276

LINK – STUDY RECORD:
https://clinicaltrials.gov/ct2/show/NCT05086276

REFERENCE:
Hearing Loss Treatment Report, Urgent Research

A Trial of LY3056480 in Patients With SNLH

September 30, 2021

CATEGORY:
Clinical Trials

TITLE:
A Trial of LY3056480 in Patients With SNLH

INTERVENTION/TREATMENT:

PHASE:

DESCRIPTION:
Condition :   Sensorineural Hearing Loss

Intervention :   Drug: LY3056480

Sponsor :   Audion Therapeutics BV

Not yet recruiting

ID:
NCT05061758

STATUS:

DATE – FIRST POSTED:
Thu, 30 Sep 2021 12:00:00 EDT

DATE – LAST UPDATE POSTED:
09/30/21 05:28PM

DATE – RETRIEVED:
09/30/21 05:28PM

LINK – STUDY HISTORY:
https://clinicaltrials.gov/ct2/history/NCT05061758

LINK – STUDY RECORD:
https://clinicaltrials.gov/ct2/show/NCT05061758

REFERENCE:
Hearing Loss Treatment Report, Urgent Research

FX-322 in Sensorineural Hearing Loss [Completed]

March 30, 2021

CATEGORY:
Clinical Trials

TITLE:
FX-322 in Sensorineural Hearing Loss

INTERVENTION/TREATMENT:

PHASE:

DESCRIPTION:
Condition :   Sensorineural Hearing Loss

Interventions :   Drug: FX-322;   Drug: Placebo

Sponsor :   Frequency Therapeutics

Completed

ID:
NCT03616223

STATUS:

DATE – FIRST POSTED:
Mon, 06 Aug 2018 12:00:00 EDT

DATE – LAST UPDATE POSTED:
03/30/21 06:51AM

DATE – RETRIEVED:
03/30/21 06:51AM

LINK – STUDY HISTORY:
https://clinicaltrials.gov/ct2/history/NCT03616223

LINK – STUDY RECORD:
https://clinicaltrials.gov/ct2/show/NCT03616223

Verification of the Efficacy/Safety of the Dual Drug Delivery for Hearing Loss

March 1, 2021

https://clinicaltrials.gov/ct2/show/NCT04766853

Verification of the Efficacy/Safety of the Dual Drug Delivery for Hearing Loss

Brief Summary:
This study is a prospective, randomized pilot study. To verify an efficacy and safety of the dual drug injectable delivery vehicle, patients who have not responded to the existing standard treatment will be enrolled. Hearing test and endoscopy of tympanic membrane will be conducted after intratympanic treatment for evaluation.

Condition or disease Intervention/treatment Phase
Hearing Loss, Sudden
Hearing Loss Ototoxic
Hearing Loss, Noise-Induced
Meniere Disease
Drug: Dexamethasone
Drug: Hyaluronic acid
Phase 1
Phase 2

Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Verification of the Efficacy / Safety of the Dual Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study)
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Efficacy of SENS-401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

November 2, 2020

https://clinicaltrials.gov/ct2/show/NCT03603314?type=Intr&cond=Hearing+Loss&lupd_s=05%2F05%2F2020&lupd_d=14&sort=nwst

Condition :   Severe Sudden Sensorineural Hearing Loss

Interventions :   Drug: SENS-401;   Other: Placebo Oral Tablet

Sponsor :   Sensorion

Recruiting

Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

NCT03603314

Fri, 27 Jul 2018 12:00:00 EDT

Last Update Posted: 05/19/20 06:40AM

FX-322 in Adults With Stable Sensorineural Hearing Loss

October 8, 2020

New item in Clinical Trial category found.

TITLE:
FX-322 in Adults With Stable Sensorineural Hearing Loss

DESCRIPTION:
Conditions :   Sensorineural Hearing Loss;   Noise Induced Hearing Loss;   Sudden Sensorineural Hearing Loss

Interventions :   Drug: FX-322;   Drug: Placebo

Sponsor :   Frequency Therapeutics

Active, not recruiting

ID:
NCT04120116

FIRST POSTED:
Wed, 09 Oct 2019 12:00:00 EDT

LAST UPDATE POSTED:
10/08/20 07:05AM

RECRUITMENT STATUS:
recruiting

INTERVENTION/DRUG:
FX-322

SOURCE LINK:
https://clinicaltrials.gov/ct2/show/NCT04120116?type=Intr&cond=Sensorineural+Hearing+Loss&phase=0124&lupd_s=10%2F07%2F2020&lupd_d=1&sort=nwst

LINK:
https://clinicaltrials.gov/ct2/show/NCT04120116

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

September 14, 2020

https://clinicaltrials.gov/ct2/show/NCT04129775?type=Intr&cond=Hearing+Loss&lupd_s=10%2F03%2F2019&lupd_d=14&sort=nwst

Condition :   Sensorineural Hearing Loss

Interventions :   Drug: OTO-413;   Drug: Placebo

Sponsor :   Otonomy, Inc.

Recruiting

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

NCT04129775

Thu, 17 Oct 2019 12:00:00 EDT

Last Update Posted: 10/17/19 08:21AM

https://clinicaltrials.gov/ct2/show/NCT04129775

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

Updated: September 14, 2020
Active, not recruiting

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-413 Given as a Single Intratympanic Injection in Subjects With Speech-in-noise Hearing Impairment
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Protective Effects of EPI-743 on Noise-Induced Hearing Loss [Completed]

August 31, 2020

https://clinicaltrials.gov/ct2/show/NCT02257983?type=Intr&cond=Hearing+Loss&lupd_s=08%2F17%2F2020&lupd_d=14&sort=nwst

Condition :   Noise-induced Hearing Loss

Interventions :   Drug: EPI-743;   Drug: Placebo

Sponsor :   PTC Therapeutics

Completed

Protective Effects of EPI-743 on Noise-Induced Hearing Loss

NCT02257983

Tue, 07 Oct 2014 12:00:00 EDT

Last Update Posted: 08/31/20 07:19AM

Phase 2a Study of FX-322 Administered by Intratympanic Injection in Adults With Stable Sensorineural Hearing Loss

April 10, 2020

https://clinicaltrials.gov/ct2/show/NCT04120116?type=Intr&cond=Hearing+Loss&lupd_s=09%2F25%2F2019&lupd_d=14&sort=nwst

Conditions :   Sensorineural Hearing Loss;   Noise Induced Hearing Loss;   Sudden Sensorineural Hearing Loss

Interventions :   Drug: FX-322;   Drug: Placebo

Sponsor :   Frequency Therapeutics

Recruiting

FX-322 in Adults With Stable Sensorineural Hearing Loss

NCT04120116

Wed, 09 Oct 2019 12:00:00 EDT

Last Update Posted: 10/09/19 10:49AM

High Dose Oral Steroids in Sudden Sensorineural Hearing Loss [Suspended] (On hold due to COVID-19 outbreak)

April 8, 2020

https://clinicaltrials.gov/ct2/show/NCT03255473

High Dose Oral Steroids in Sudden Sensorineural Hearing Loss

Study Type : Interventional
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL within six weeks, and compare side effect profiles between the two treatment regimens of either dexamethasone or prednisone.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : February 2020

Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss [Completed]

March 18, 2020

https://clinicaltrials.gov/ct2/show/NCT02132130?type=Intr&cond=Hearing+Loss&lupd_s=04%2F29%2F2019&lupd_d=14&sort=nwst

Condition :   Unilateral Severe to Profound Hearing Loss OR Bilateral Severe to Profound Hearing Loss

Intervention :   Drug: CGF166

Sponsor :   Novartis Pharmaceuticals

Recruiting

Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss

NCT02132130

Wed, 07 May 2014 12:00:00 EDT

Last Update Posted: 05/13/19 07:50AM

A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)

August 24, 2018

https://clinicaltrials.gov/ct2/show/NCT02779192

A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)

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