Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Unilateral Hearing Loss

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43917   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    26 result(s) found for: Unilateral Hearing Loss. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2008-000132-40 Sponsor Protocol Number: AM-111-CL-08-01 Start Date*: 2008-11-18
    Sponsor Name:Auris Medical AG
    Full Title: Efficacy of AM 111 in Patients with Acute Sensorineural Hearing Loss: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalation Phase II Study
    Medical condition: Acute sensorineural hearing loss (ASNHL), which may be triggered by acoustic trauma, middle or inner ear surgery, i.e. known or evident insults to the inner ear. ASNHL may also result from a variet...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10013993 - Ear and labyrinth disorders 10040016 Sensorineural hearing loss LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2017-000658-20 Sponsor Protocol Number: 7621 Start Date*: 2017-04-24
    Sponsor Name:
    Full Title: Combinated systemic and intratympanic steroid therapy in idiopathic sudden sensorineural hearing loss
    Medical condition: Idiopathic Sudden Sensorineural Hearing Loss
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-003268-29 Sponsor Protocol Number: OTI2013 Start Date*: 2013-10-17
    Sponsor Name:AUSL Piacenza
    Full Title: Hyperbaric oxygen therapy in the treatment of sudden hydiopatic sensorineural hearing loss
    Medical condition: Sudden Sensorineural Hearing Loss
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-000242-22 Sponsor Protocol Number: STR001-202 Start Date*: 2017-06-28
    Sponsor Name:STREKIN AG
    Full Title: A Phase III multicenter, double-blind, placebo-controlled, study evaluating the safety, and efficacy of STR001 treatment in adults with Sudden Sensorineural Hearing Loss
    Medical condition: Sudden Sensorineural Hearing Loss (SSHL) including - idiopathic unilateral Sensorineural Hearing Loss - acute uni- or bilateral acoustic trauma-induced Sensorineural Hearing Loss
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004854 10040016 Sensorineural hearing loss LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-000812-47 Sponsor Protocol Number: SENS401-201 Start Date*: 2018-09-24
    Sponsor Name:SENSORION SA
    Full Title: A two- part, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of SENS-401 in subjects with severe or profound sudden sensorineural hearing loss
    Medical condition: Sudden sensorineural hearing loss (SSNHL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004854 10040016 Sensorineural hearing loss LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) BG (Completed) CZ (Completed) GB (GB - no longer in EU/EEA) DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-002602-36 Sponsor Protocol Number: KKSH-127 Start Date*: 2016-06-21
    Sponsor Name:Martin-Luther-Universität Halle-Wittenberg
    Full Title: Efficacy and safety of high dose glucocorticosteroid treatment for idiopathic sudden sensorineural hearing loss (HODOKORT)
    Medical condition: Idiopathic sudden sensorineural hearing loss
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-000066-37 Sponsor Protocol Number: NM-V-101 Start Date*: 2013-01-16
    Sponsor Name:Nordmark Arzneimittel GmbH & Co. KG
    Full Title: Double-blind, randomized, placebo-controlled study on efficacy, safety and tolerability of ancrod in patients with sudden sensorineural hearing loss
    Medical condition: sudden sensorineural hearing loss (SSHL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004854 10040016 Sensorineural hearing loss LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-005166-58 Sponsor Protocol Number: AM-111-CL-15-01 Start Date*: 2017-10-12
    Sponsor Name:Auris Medical Inc.
    Full Title: Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment (ASSENT)
    Medical condition: Idiopathic sudden sensorineural hearing loss.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10013993 - Ear and labyrinth disorders 10061373 Sudden hearing loss PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2008-004803-78 Sponsor Protocol Number: 1.1 Start Date*: 2009-03-20
    Sponsor Name:Imperial College London
    Full Title: Effectiveness of Transtympanic Steroids in unilateral Ménière's disease: a Randomised Controlled Double-Blind Trial
    Medical condition: refractory unilateral Meniere's disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10000641 Active Meniere's disease, cochleovestibular LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-004323-33 Sponsor Protocol Number: AC102-201 Start Date*: 2022-05-06
    Sponsor Name:AudioCure Pharma GmbH
    Full Title: Phase II, Multi-Center, Randomized, Blinded Study Evaluating the Efficacy, Safety and Tolerability of a Single Intratympanic Dose of AC102 Compared to Oral Steroids for the Treatment of Idiopathic ...
    Medical condition: Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL) ISSNHL is most commonly defined as sensorineural hearing loss of 30dB or greater over at least three contiguous audiometric frequencies occurri...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) CZ (Ongoing) BG (Prematurely Ended) AT (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-002077-21 Sponsor Protocol Number: AM-111-CL-13-01 Start Date*: 2015-10-15
    Sponsor Name:Auris Medical AG
    Full Title: Efficacy and Safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss
    Medical condition: Idiopathic sudden sensorineural hearing loss
    Disease: Version SOC Term Classification Code Term Level
    19.1 10013993 - Ear and labyrinth disorders 10043882 Tinnitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) HU (Completed) ES (Prematurely Ended) DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2022-000079-38 Sponsor Protocol Number: DB-OTO-001 Start Date*: 2023-05-09
    Sponsor Name:Decibel Therapeutics
    Full Title: A Phase 1/2, Open-Label, Multicenter Trial With a Single Ascending Dose Cohort With Unilateral Intracochlear Injection Followed by a Bilateral Injection Expansion Cohort to Evaluate the Safety, Tol...
    Medical condition: Congenital auditory neuropathy secondary to biallelic mutations of the otoferlin gene (hOTOF)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004854 10011874 Deaf LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-003068-30 Sponsor Protocol Number: CMV-MM-2 Start Date*: 2013-09-30
    Sponsor Name:LUMC
    Full Title: CONgenital Cytomegalovirus: Efficacy of antiviral treatment in a non-Randomized Trial with historical control group
    Medical condition: Congenital cytomegalovirus infection. Sensorineural Hearingloss.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10010420 Congenital CMV infection LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-005378-44 Sponsor Protocol Number: CMV-MM-1 Start Date*: 2012-05-03
    Sponsor Name:LUMC
    Full Title: CONgenital Cmv: Efficacy of antiviral treatment in a Randomized controlled Trial
    Medical condition: Congenital cytomegalovirus infection. Sensorineural Hearingloss.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10010420 Congenital CMV infection LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-004496-71 Sponsor Protocol Number: 104-201508 Start Date*: 2016-03-01
    Sponsor Name:Otonomy Inc.
    Full Title: A prospective, randomized, double blind, placebo-controlled, multicenter, Phase 3 efficacy and safety study of OTO-104 given as a single intratympanic injection in subjects with unilateral Meniere’...
    Medical condition: Meniere's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10013993 - Ear and labyrinth disorders 10027183 Meniere's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) BE (Completed) DE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001464-35 Sponsor Protocol Number: 104-201811 Start Date*: 2018-11-06
    Sponsor Name:Otonomy, Inc.
    Full Title: A prospective, randomized, double blind, placebo-controlled, multicenter, Phase 3 efficacy and safety study of OTO-104 given as a single intratympanic injection in subjects with unilateral Meniere’...
    Medical condition: Meniere's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10013993 - Ear and labyrinth disorders 10027183 Meniere's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-002261-18 Sponsor Protocol Number: M05-2013 Start Date*: 2013-08-21
    Sponsor Name:Synphora AB
    Full Title: A randomized, double-blind, placebo-controlled, parallel group study to determine the efficacy, the duration of action, and safety of latanoprost in patients with Menière’s disease
    Medical condition: Menière´s disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2014-001337-86 Sponsor Protocol Number: 104-201403 Start Date*: 2014-07-11
    Sponsor Name:Otonomy Inc.
    Full Title: A 6-month, prospective, randomized, multicenter, placebo-controlled safety study of OTO-104 given at 3-month intervals by intratympanic injection in subjects with unilateral Meniere's disease, foll...
    Medical condition: Meniere's disease
    Disease: Version SOC Term Classification Code Term Level
    17.0 10013993 - Ear and labyrinth disorders 10027183 Meniere's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-000766-29 Sponsor Protocol Number: 104-201610 Start Date*: 2016-07-29
    Sponsor Name:Otonomy Inc.
    Full Title: A 6-MONTH, MULTICENTER, PHASE 3, OPEN-LABEL EXTENSION SAFETY STUDY OF OTO-104 GIVEN AT 3-MONTH INTERVALS BY INTRATYMPANIC INJECTION IN SUBJECTS WITH UNILATERAL MENIERE’S DISEASE
    Medical condition: Meniere's disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 10013993 - Ear and labyrinth disorders 10027183 Meniere's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) BE (Completed) DE (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-005246-42 Sponsor Protocol Number: 0796-19 Start Date*: 2021-12-28
    Sponsor Name:INTAS PHARMACEUTICALS LIMITED
    Full Title: A Multicenter, Three- arm, Double- blind, Double dummy, Parallel-group, placebo controlled Study for efficacy and safety evaluation of prolonged release formulation of Betahistine PR 48 mg once dai...
    Medical condition: Menière´s disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10013993 - Ear and labyrinth disorders 10047340 Vertigo PT
    20.0 10013993 - Ear and labyrinth disorders 10022398 Inner ear signs and symptoms HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Ongoing)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA