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Clinical trials for Sphingomyelin

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    18 result(s) found for: Sphingomyelin. Displaying page 1 of 1.
    EudraCT Number: 2006-005842-35 Sponsor Protocol Number: FARM59T23W Start Date*: 2006-11-22
    Sponsor Name:Dipartimento di Pediatria Universita` di Napoli Federico II
    Full Title: Efficacy and safety of treatment with N-butyl-deoxynojirimycin (NB-DNJ-miglustat) in patients with Niemann-Pick disease type C.
    Medical condition: NIEMANN-PICK DISEASE TYPE C
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029403 LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003198-40 Sponsor Protocol Number: DFI13803 Start Date*: 2015-02-19
    Sponsor Name:Genzyme Corporation
    Full Title: A phase 1/2, multi-center, open-label, ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of olipudase alfa in pediatric patients...
    Medical condition: Patients with acid sphingomyelinase deficiency (Niemann-Pick disease)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10041515 Sphingomyelin lipidosis LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) FR (Completed) DE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-023953-12 Sponsor Protocol Number: DFI12712 Start Date*: 2013-12-16
    Sponsor Name:Genzyme Corporation
    Full Title: A Phase 2, Multi-Center, Randomized, Open-Label, Repeat Dose, Dose-Comparison Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Human Acid Sphingomyelinase in Patients Wit...
    Medical condition: Patients with acid sphingomyelinase deficiency (Niemann-Pick Type B disease)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10041515 Sphingomyelin lipidosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-002514-16 Sponsor Protocol Number: AC-056C405 Start Date*: 2022-07-29
    Sponsor Name:Actelion Pharmaceuticals Trading (Shanghai) Co., Ltd
    Full Title: A single-arm uncontrolled 12-month Clinical Study to evaluate the Safety and Efficacy of miglustat (Zavesca®) for the Treatment of Niemann-Pick Disease Type C (NPC) in Chinese subjects
    Medical condition: Niemann-Pick Disease Type C (NPC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10029403 Niemann-Pick disease PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-000051-40 Sponsor Protocol Number: LTS13632 Start Date*: 2013-12-16
    Sponsor Name:Genzyme Corporation
    Full Title: A Long-Term Study to Assess the Ongoing Safety and Efficacy of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency
    Medical condition: Patients with acid sphingomyelinase deficiency (Niemann-Pick Type B disease)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10041515 Sphingomyelin lipidosis LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Ongoing) DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-005194-37 Sponsor Protocol Number: CT-ORZY-NPC-001 Start Date*: 2015-10-19
    Sponsor Name:Orphazyme ApS
    Full Title: A prospective non-therapeutic study in patients diagnosed with Niemann-Pick disease type C in order to characterise the individual patient disease profile and historic signo-symptomatology progress...
    Medical condition: Niemann-Pick disease - type C
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10029403 Niemann-Pick disease PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-000371-26 Sponsor Protocol Number: DFI12712 Start Date*: 2015-08-14
    Sponsor Name:Genzyme Corporation
    Full Title: A Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Repeat Dose Study to Evaluate the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of olipudase alfa in Patients With...
    Medical condition: Patients with acid sphingomyelinase deficiency (Niemann-Pick Type B disease)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10041515 Sphingomyelin lipidosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) FR (Completed) PT (Completed) ES (Ongoing) IT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-004438-93 Sponsor Protocol Number: CT-ORZY-NPC-002 Start Date*: 2016-05-09
    Sponsor Name:Orphazyme A/S
    Full Title: Arimoclomol prospective double blind, randomised, placebo-controlled study in patients diagnosed with Niemann Pick disease type C
    Medical condition: Niemann Pick disease type C
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10029403 Niemann-Pick disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed) DE (Ongoing) IT (Ongoing) PL (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2020-003136-25 Sponsor Protocol Number: CTD-TCNPC-301 Start Date*: 2021-10-25
    Sponsor Name:Cyclo Therapeutics, Inc.
    Full Title: A Phase 3, Double blind, Randomized, Placebo controlled, Parallel group, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of 2000 mg/kg of Trappsol® Cyclo™ (Hydroxypropyl β cycl...
    Medical condition: Niemann Pick Disease Type C1
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10029403 Niemann-Pick disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing) DE (Ongoing) PL (Ongoing) IT (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001666-10 Sponsor Protocol Number: 20140415 Start Date*: 2014-06-24
    Sponsor Name:Academic Medical Center Amsterdam
    Full Title: Local delivery of CER-001 in advanced plaques Proof-of-concept for apoA-1 as initiator of reverse cholesterol transport (LOCATION)
    Medical condition: Atherosclerosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-000724-10 Sponsor Protocol Number: 60978 Start Date*: 2018-07-04
    Sponsor Name:Academic Medical Center
    Full Title: Targeting esophageal cancer with HDL nanoparticles: an imaging study
    Medical condition: Primary esophageal cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-005761-23 Sponsor Protocol Number: CTD-TCNPC-201 Start Date*: 2016-09-26
    Sponsor Name:Cyclo Therapeutics, Inc.
    Full Title: A Phase I/II study to evaluate the safety and pharmacokinetics of intravenous Trappsol Cyclo (HP-β-CD) in patients with Niemann-Pick disease type C (NPC-1) and the pharmacodynamic effects of treatm...
    Medical condition: Niemann-Pick disease type C
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10029403 Niemann-Pick disease PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2010-023611-34 Sponsor Protocol Number: NLCER-001-CLIN-002 Start Date*: 2011-05-18
    Sponsor Name:Cerenis Therapeutics
    Full Title: A Phase II Multi-Center, Double-Blind, Ascending Dose, Placebo-Controlled, Dose-Finding Trial of CER-001 or Placebo in Subjects with Acute Coronary Syndrome
    Medical condition: Symptoms of Acute Coronary Syndrome
    Disease: Version SOC Term Classification Code Term Level
    12.1 10051592 Acute coronary syndrome LLT
    12.1 10051592 Acute coronary syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001381-26 Sponsor Protocol Number: CER-001-CLIN-010 Start Date*: 2015-07-22
    Sponsor Name:CERENIS THERAPEUTICS SA
    Full Title: A PHASE II MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-FOCUSING TRIAL OF CER-001 IN SUBJECTS WITH ACUTE CORONARY SYNDROME
    Medical condition: Acute Coronary Syndrome (ACS) with significant plaque volume
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-006188-23 Sponsor Protocol Number: CER-001-CLIN-007 Start Date*: 2012-02-14
    Sponsor Name:Cerenis Therapeutics
    Full Title: CER-001 Infusions in Subjects with Familial HDL-c Deficiency
    Medical condition: Familial HDL-c Deficiency
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10020604 Hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004331-71 Sponsor Protocol Number: IB1001-201 Start Date*: 2019-05-08
    Sponsor Name:IntraBio Ltd
    Full Title: Effects of N-Acetyl-L-Leucine on Niemann-Pick type C Disease (NPC): A multinational, multi-center, open-label, rater-blinded Phase II study
    Medical condition: Niemann-Pick Disease type C (NPC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) SK (Completed)
    Trial results: View results
    EudraCT Number: 2011-003998-28 Sponsor Protocol Number: CER-001-CLIN-003 Start Date*: 2012-01-24
    Sponsor Name:Cerenis Therapeutics
    Full Title: Modifying Orphan Disease Evaluation (MODE) Study: A Multicenter, Open-Label Study of the Effects of CER-001 on Plaque Volume in Subjects with Homozygous Familial Hypercholesterolemia (HoFH)
    Medical condition: homozygous familial hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    15.0 10027433 - Metabolism and nutrition disorders 10020604 Hypercholesterolemia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003713-23 Sponsor Protocol Number: CER-001-CLIN-009 Start Date*: 2015-11-11
    Sponsor Name:CERENIS THERAPEUTICS SA
    Full Title: PHASE III, MULTI-CENTER, RANDOMIZED, 48 WEEKS, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CER-001 ON VESSEL WALL AREA IN PATIENTS WITH GENETICALLY DEF...
    Medical condition: GENETICALLY DEFINED FAMILIAL PRIMARY HYPOALPHALIPOPROTEINEMIA (FPHA mutation in ApoA1 and/or ABCA1 gene)
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004848 10019185 HDL cholesterol decreased LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) BE (Prematurely Ended) FR (Prematurely Ended)
    Trial results: View results
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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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