Hearing Loss Treatment Report

www.HearingLossTreatmentReport.com

Clinical Trials

FX-322 in Adults With Severe Sensorineural Hearing Loss

CATEGORY:
Clinical Trials

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

INTERVENTION/TREATMENT:

PHASE:

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

Interventions :   Drug: FX-322;   Other: Placebo

Sponsor :   Frequency Therapeutics

Recruiting

ID:
NCT04629664

STATUS:

DATE – FIRST POSTED:
Mon, 16 Nov 2020 12:00:00 EST

DATE – LAST UPDATE POSTED:
07/06/21 07:55AM

DATE – RETRIEVED:
07/06/21 07:55AM

LINK – STUDY HISTORY:
https://clinicaltrials.gov/ct2/history/NCT04629664

LINK – STUDY RECORD:
https://clinicaltrials.gov/ct2/show/NCT04629664

REFERENCE:
Hearing Loss Treatment Report, Urgent Research

Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss [Completed]

CATEGORY:
Clinical Trials

TITLE:
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss

INTERVENTION/TREATMENT:

PHASE:

DESCRIPTION:
Condition :   Sensorineural Hearing Loss

Interventions :   Drug: PIPE-505;   Drug: Diluent alone

Sponsor :   Pipeline Therapeutics, Inc.

Completed

ID:
NCT04462198

STATUS:

DATE – FIRST POSTED:
Wed, 08 Jul 2020 12:00:00 EDT

DATE – LAST UPDATE POSTED:
06/24/21 11:34AM

DATE – RETRIEVED:
06/24/21 11:34AM

LINK – STUDY HISTORY:
https://clinicaltrials.gov/ct2/history/NCT04462198

LINK – STUDY RECORD:
https://clinicaltrials.gov/ct2/show/NCT04462198

REFERENCE:
Hearing Loss Treatment Report, Urgent Research

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

CATEGORY:
Clinical Trials

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

INTERVENTION/TREATMENT:

PHASE:

DESCRIPTION:
Condition :   Sensorineural Hearing Loss

Interventions :   Drug: OTO-413;   Drug: Placebo

Sponsor :   Otonomy, Inc.

Recruiting

ID:
NCT04129775

STATUS:

DATE – FIRST POSTED:
Thu, 17 Oct 2019 12:00:00 EDT

DATE – LAST UPDATE POSTED:
06/18/21 05:20PM

DATE – RETRIEVED:
06/18/21 05:20PM

LINK – STUDY HISTORY:
https://clinicaltrials.gov/ct2/history/NCT04129775

LINK – STUDY RECORD:
https://clinicaltrials.gov/ct2/show/NCT04129775

FX-322 in Sensorineural Hearing Loss [Completed]

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

Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss

CATEGORY:
Clinical Trials

TITLE:
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss

INTERVENTION/TREATMENT:

PHASE:

DESCRIPTION:
Condition :   Sensorineural Hearing Loss

Interventions :   Drug: PIPE-505;   Drug: Diluent alone

Sponsor :   Pipeline Therapeutics, Inc.

Recruiting

ID:
NCT04462198

STATUS:

DATE – FIRST POSTED:
Wed, 08 Jul 2020 12:00:00 EDT

DATE – LAST UPDATE POSTED:
10/14/20 08:47PM

DATE – RETRIEVED:
10/14/20 08:47PM

LINK – STUDY HISTORY:
https://clinicaltrials.gov/ct2/history/NCT04462198

LINK – STUDY RECORD:
https://clinicaltrials.gov/ct2/show/NCT04462198

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

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

FX-322 in Adults With Age-Related Sensorineural Hearing Loss

CATEGORY:
Clinical Trials

TITLE:
FX-322 in Adults With Age-Related Sensorineural Hearing Loss

INTERVENTION/TREATMENT:

PHASE:

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

Interventions :   Drug: FX-322;   Other: placebo

Sponsor :   Frequency Therapeutics

Recruiting

ID:
NCT04601909

STATUS:

DATE – FIRST POSTED:
Mon, 26 Oct 2020 12:00:00 EDT

DATE – LAST UPDATE POSTED:
10/26/20 07:11AM

DATE – RETRIEVED:
10/26/20 07:11AM

LINK – STUDY HISTORY:
https://clinicaltrials.gov/ct2/history/NCT04601909

LINK – STUDY RECORD:
https://clinicaltrials.gov/ct2/show/NCT04601909

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

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

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

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]

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

Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment [Terminated]

https://clinicaltrials.gov/ct2/show/NCT02809118?type=Intr&cond=Hearing+Loss&lupd_s=07%2F24%2F2020&lupd_d=14&sort=nwst

Condition :   Hearing Loss, Idiopathic Sudden Sensorineural

Interventions :   Drug: AM-111 0.4 mg/ml;   Drug: AM-111 0.8 mg/ml;   Other: Placebo

Sponsor :   Auris Medical, Inc.

Terminated

Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment

NCT02809118

Wed, 22 Jun 2016 12:00:00 EDT

Last Update Posted: 08/07/20 06:52AM

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

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)

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 and Efficacy of STR001-IT and STR001-ER in Patients With SSHL [Completed]

https://clinicaltrials.gov/ct2/show/NCT03331627?type=Intr&cond=Hearing+Loss&lupd_s=03%2F27%2F2019&lupd_d=14&sort=nwst

Condition :   Acute Hearing Loss

Intervention :   Drug: STR001-IT and STR001-ER

Sponsor :   Strekin AG

Recruiting

Safety and Efficacy of STR001-IT and STR001-ER in Patients With SSHL

NCT03331627

Mon, 06 Nov 2017 12:00:00 EST

Last Update Posted: 04/10/19 08:35AM

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

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

Intratympanic Steroids for Sudden Hearing Loss

https://clinicaltrials.gov/ct2/show/NCT04129697?type=Intr&cond=Hearing+Loss&lupd_s=10%2F03%2F2019&lupd_d=14&sort=nwst

Condition :   Dexamethasone or Methylprednisolone; Sudden Hearing Loss; Intratympanic Steroid

Intervention :   Drug: Dexamethasone or Methylprednisolone

Sponsor :   Second Affiliated Hospital, School of Medicine, Zhejiang University

Not yet recruiting

Intratympanic Steroids for Sudden Hearing Loss

NCT04129697

Thu, 17 Oct 2019 12:00:00 EDT

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

Vestibular Prognosis Assessment of ISSNHL With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids

https://clinicaltrials.gov/ct2/show/NCT03974867?type=Intr&cond=Hearing+Loss&lupd_s=05%2F22%2F2019&lupd_d=14&sort=nwst

Conditions :   Vestibular Vertigo;   Sudden Hearing Loss

Interventions :   Drug: Prednisone 5Mg Tab;   Drug: Methylprednisolone 40 mg

Sponsor :   Eye & ENT Hospital of Fudan University

Not yet recruiting

Vestibular Prognosis Assessment of ISSNHL With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids

NCT03974867

Wed, 05 Jun 2019 12:00:00 EDT

Last Update Posted: 06/05/19 07:52AM

Phase 3 Clinical Trial: D-methionine to Reduce Noise-Induced Hearing Loss (NIHL) [Terminated]

https://clinicaltrials.gov/ct2/show/NCT02903355?type=Intr&cond=Hearing+Loss&lupd_s=04%2F15%2F2019&lupd_d=14&sort=nwst

Condition :   Noise-induced Hearing Loss

Interventions :   Drug: D-methionine;   Drug: Placebo

Sponsor :   Southern Illinois University

Terminated

Phase 3 Clinical Trial: D-methionine to Reduce Noise-Induced Hearing Loss (NIHL)

NCT02903355

Fri, 16 Sep 2016 12:00:00 EDT

Last Update Posted: 04/29/19 08:25AM

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