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Clinical trials for Neonatal abstinence syndrome

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
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    The EU Clinical Trials Register currently displays   44341   clinical trials with a EudraCT protocol, of which   7370   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 ).  
     
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    26 result(s) found for: Neonatal abstinence syndrome. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2019-004394-10 Sponsor Protocol Number: ACT16248 Start Date*: 2020-06-30
    Sponsor Name:Genzyme Corporation
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of Lademirsen (SAR339375) for Subcutaneous Injection Administe...
    Medical condition: Congenital, hereditary and neonatal diseases
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10001843 Alport's syndrome PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-002980-26 Sponsor Protocol Number: CACZ885A2102 Start Date*: 2004-12-10
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label, phase II dose titration study of ACZ885 (human anti-IL-1beta monoclonal antibody) to assess the clinical efficacy, safety, pharmacokinetics and pharmacodynamics in patients with NALP...
    Medical condition: Muckle-Wells Syndrome: rare hereditary, autosomal dominant, systemic inflammatory disease, characterized by recurrent episodes of fever, arthralgia, myalgia, urticarial rash, and conjunctivitis. La...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Completed) FR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-001429-32 Sponsor Protocol Number: CACZ885D2201 Start Date*: 2012-03-09
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-center, open label, 24-month treatment study to establish the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of canakinumab (anti-IL-1 beta antibody) in patients with...
    Medical condition: Neonatal onset multisystem inflammatory disease (abbreviated NOMID, also known as chronic infantile neurologic cutaneous and articular syndrome or CINCA)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10068850 Cryopyrin associated periodic syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-000300-42 Sponsor Protocol Number: 03AR0298 Start Date*: 2013-01-18
    Sponsor Name:National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    Full Title: A long-term outcome study with the IL-1 receptor antagonist Anakinra/Kineret® in patients with Neonatal onset multisystem inflammatory disease (Nomid/Cinca syndrome)
    Medical condition: neonatal onset multisystem inflammatory disease (NOMID/CINCA)
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-003210-39 Sponsor Protocol Number: SXR001 Start Date*: 2021-11-23
    Sponsor Name:Sixera Pharma
    Full Title: A phase I/II, multicenter, randomized, double-blind, placebo within-patient controlled, first-time-in-man (FTIM) Proof of Concept (PoC) study to evaluate the safety and efficacy of topically applie...
    Medical condition: Netherton-syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10062909 Netherton's syndrome PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FI (Completed) SE (Trial now transitioned) AT (Trial now transitioned) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000660-33 Sponsor Protocol Number: ZAF-312 Start Date*: 2015-09-30
    Sponsor Name:Zafgen Inc.
    Full Title: Randomized, Double-Blind, Placebo Controlled, Phase 3 Trial of Beloranib in Obese Subjects with Prader-Willi Syndrome to Evaluate Food-related Behavior, Total Body Weight, and Safety Over 52 Weeks
    Medical condition: Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10036476 Prader-Willi syndrome PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) ES (Prematurely Ended) BE (Prematurely Ended) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001263-23 Sponsor Protocol Number: BP27832 Start Date*: 2014-03-19
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF RO5186582 IN ADULTS AND ADOLESCENTS WITH DOWN SYNDROME (CLEMATIS)
    Medical condition: Down Syndrome
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10044688 Trisomy 21 PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-004948-11 Sponsor Protocol Number: E2020-A001-335 Start Date*: 2017-03-09
    Sponsor Name:Eisai Inc.
    Full Title: A 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With D...
    Medical condition: Down Syndrome, Cognitive Dysfunction
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-003083-13 Sponsor Protocol Number: 250-202 Start Date*: Information not available in EudraCT
    Sponsor Name:Allievex Corporation
    Full Title: A Multicenter, Multinational, Extension Study to Evaluate the Long-Term Safety and Efficacy of Intracerebroventricular AX 250 in Patients with Mucopolysaccharidosis Type IIIB (MPS IIIB, Sanfilippo ...
    Medical condition: Mucopolysaccharidosis Type IIIB (Sanfilippo Syndrome Type B, MPS IIIB)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    20.0 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Prematurely Ended) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2020-000489-40 Sponsor Protocol Number: IZD174-002 Start Date*: 2020-09-22
    Sponsor Name:Inflazome (Australia) Pty Ltd.
    Full Title: A Multi-Centre, Randomised, Open-Label, Phase IIb Study to Evaluate the Safety, Tolerability and Efficacy of IZD174 in Patients with Cryopyrin Associated Periodic Syndromes
    Medical condition: Cryopyrin-associated periodic syndrome (CAPS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068850 Cryopyrin associated periodic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-004011-28 Sponsor Protocol Number: A4250-012 Start Date*: 2021-01-26
    Sponsor Name:Albireo AB
    Full Title: A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT)
    Medical condition: Alagille Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed) PL (Completed) NL (Completed) BE (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000996-36 Sponsor Protocol Number: A4250-015 Start Date*: 2021-10-14
    Sponsor Name:Albireo AB
    Full Title: An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT)
    Medical condition: Alagille Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned) PL (Trial now transitioned) NL (Trial now transitioned) DE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003200-14 Sponsor Protocol Number: JR-141-GS31 Start Date*: 2022-05-16
    Sponsor Name:JCR Pharmaceuticals Co., Ltd.
    Full Title: A Phase III study of JR-141 in Mucopolysaccharidosis type II (Hunter Syndrome) patients.
    Medical condition: Mucopolysaccharidosis type II
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004547-21 Sponsor Protocol Number: ZP4207-17109 Start Date*: 2018-08-24
    Sponsor Name:Zealand Pharma A/S
    Full Title: A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism
    Medical condition: Children with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-004546-15 Sponsor Protocol Number: ZP4207-17106 Start Date*: 2018-08-24
    Sponsor Name:Zealand Pharma A/S
    Full Title: An Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism
    Medical condition: Children with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-003572-23 Sponsor Protocol Number: GCP#01.01.030 Start Date*: 2017-12-27
    Sponsor Name:Gamida Cell Ltd
    Full Title: Allogeneic Stem Cell Transplantation of CordIn™, Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Patients with Hemoglobinopathies
    Medical condition: Hemoglobinopathies
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10054658 Thalassemia LLT
    18.0 100000004850 10040645 Sickle cell disease NOS LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-001489-41 Sponsor Protocol Number: P00003466 Start Date*: 2018-07-02
    Sponsor Name:Karolinska Universitetssjukhuset
    Full Title: Radiation- and alkylator-free hematopoietic cell transplantation for bone marrow failure due to dyskeratosis congenita / telomere disease
    Medical condition: Dyskeratosis congenita / telomere disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10001756 Allogenic bone marrow transplantation therapy PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002502-31 Sponsor Protocol Number: RP-L102-0118 Start Date*: 2018-10-31
    Sponsor Name:Rocket Pharmaceuticals, Inc.
    Full Title: A Phase II Clinical Trial to Evaluate the Efficacy of the Infusion of Autologous CD34+ Cells Transduced with a Lentiviral Vector Carrying the FANCA Gene (Orphan Drug) in Patients with Fanconi Anemi...
    Medical condition: Fanconi anemia (subtype A)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10055206 Fanconi's anemia LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-003242-22 Sponsor Protocol Number: BCX4161-303 Start Date*: 2015-12-17
    Sponsor Name:BioCryst Pharmaceuticals Inc
    Full Title: OPuS-4: An open-label study to evaluate the long-term safety of avoralstat in subjects with hereditary angioedema
    Medical condition: Hereditary Angioedema
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Prematurely Ended) BE (Completed) FR (Prematurely Ended) GB (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-000208-13 Sponsor Protocol Number: ACE-536-B-THAL-004 Start Date*: 2019-12-09
    Sponsor Name:Celgene Corporation
    Full Title: A phase 2a study to evaluate the safety and pharmacokinetics of Luspatercept (ACE-536) in paediatric participants who require regular red blood cell transfusions due to beta (β) thalassemia
    Medical condition: Beta-Thalassemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10054660 Thalassemia beta LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) GR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
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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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