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Clinical trials for BAEP

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   44335   clinical trials with a EudraCT protocol, of which   7366   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.
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    5 result(s) found for: BAEP. Displaying page 1 of 1.
    EudraCT Number: 2020-001509-21 Sponsor Protocol Number: B7981037 Start Date*: 2020-12-08
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 2a, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY INVESTIGATING THE SAFETY OF RITLECITINIB (PF 06651600) IN ADULT PARTICIPANTS WITH ALOPECIA AREATA
    Medical condition: Alopecia areata
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10001761 Alopecia areata PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-001466-42 Sponsor Protocol Number: 17-HPNCL-02 Start Date*: Information not available in EudraCT
    Sponsor Name:Fondation Lenval - Hôpitaux Pédiatriques de Nice CHULENVAL
    Full Title: EFFECTIVENESS OF INTRANASAL DEXMEDETOMIDINE FOR SEDATED AUDITORY BRAINSTEM RESPONSE TESTING
    Medical condition: Child requiring auditory evaluation in a context of suspicion of deafness, language delay, overall developmental delay, risk factors for hearing loss.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022891 - Investigations 10049507 Brain stem auditory evoked response PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000359-26 Sponsor Protocol Number: ESTEVE-SANF-201 Start Date*: 2016-04-29
    Sponsor Name:Laboratorios del Dr. Esteve, S.A.
    Full Title: Phase I/II safety, tolerability and initial efficacy study of adeno-associated viral vector serotype 9 containing human sulfamidase gene after intracerebroventricular administration to patients wit...
    Medical condition: Mucopolysaccharidosis type IIIA (Sanfilippo A syndrome) is an inherited lysosomal storage disease caused by a specific lysosomal enzyme deficiency that leads to intracellular accumulation of the ...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002317-19 Sponsor Protocol Number: KKSH155 Start Date*: 2020-04-17
    Sponsor Name:Martin-Luther-Universität Halle-Wittenberg
    Full Title: Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery: a randomized multi-center phase III trial
    Medical condition: Vestibular schwannomas with indication for surgery
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10048925 Acoustic schwannoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-003210-33 Sponsor Protocol Number: ERPME01 Start Date*: 2007-08-03
    Sponsor Name:Department of Neurology, Turku University Hospital
    Full Title: Effect of ropinirole hydrochloride in progressive myoclonic epilepsy of Unverricht–Lundborg type
    Medical condition: Progressive myoclonus epilepsy of the Unverricht–Lundborg disease (ULD) type
    Disease: Version SOC Term Classification Code Term Level
    9.1 10054895 Baltic myoclonic epilepsy PT
    Population Age: Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
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    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.
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    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.

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