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Clinical trials for Natalizumab

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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    66 result(s) found for: Natalizumab. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2004-003839-31 Sponsor Protocol Number: ELN100226-CD354 Start Date*: 2005-02-05
    Sponsor Name:Elan Pharma Ltd.
    Full Title: A Phase III, Multicenter, Open-Label, Long-Term Study of the Tolerability of Intravenous Natalizumab in Crohn's Disease Subjects Who Have Previously Participated in Natalizumab Crohn's Disease Stud...
    Medical condition: Crohn's Disease (CD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002566-13 Sponsor Protocol Number: NEXT-MS Start Date*: 2019-12-19
    Sponsor Name:Amsterdam University Medical Center
    Full Title: Personalized extended interval dosing of natalizumab in relapsing remitting multiple sclerosis
    Medical condition: Relapsing remitting multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004852 10070425 Multiple sclerosis exacerbation LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000345-31 Sponsor Protocol Number: NL56584.092.16 Start Date*: 2016-09-30
    Sponsor Name:VU medical center
    Full Title: Towards personalized dosing of natalizumab in multiple sclerosis
    Medical condition: multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004852 10070425 Multiple sclerosis exacerbation LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-004040-30 Sponsor Protocol Number: EOC.NSI.11.01 Start Date*: 2013-05-24
    Sponsor Name:Ospedale Regionale di Lugano
    Full Title: Natalizumab de-escalation to interferon-beta-1b in patients with relapsing-remitting multiple sclerosis: A multicenter study
    Medical condition: relapse-remitting multiple sclerosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-000917-30 Sponsor Protocol Number: 101MS207 Start Date*: 2014-11-25
    Sponsor Name:Biogen Idec Research Limited
    Full Title: A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis
    Medical condition: Multiple Sclerosis (MS)
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029205 - Nervous system disorders 10048393 Multiple sclerosis relapse PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) IT (Prematurely Ended) DK (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-000675-13 Sponsor Protocol Number: PNS2014-01 Start Date*: 2016-02-03
    Sponsor Name:Erasmus University Medical Center
    Full Title: Natalizumab (Tysabri®) for the treatment of anti-Hu associated paraneoplastic neurological syndromes
    Medical condition: Anti-Hu associated paraneoplastic neurological syndromes
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002145-11 Sponsor Protocol Number: 101MS329 Start Date*: 2019-03-21
    Sponsor Name:Biogen Idec Research Limited
    Full Title: A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Rela...
    Medical condition: Relapsing-remitting multiple sclerosis (RRMS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) FR (Completed) NL (Completed) ES (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-000047-18 Sponsor Protocol Number: C-1808 Start Date*: 2004-07-27
    Sponsor Name:Biogen Idec Ltd.
    Full Title: An open-label, multicenter extension study to evaluate the safety and tolerability of natalizumab in subjects with multiple sclerosis who have completed studies C-1801, C-1802, or C-1803.
    Medical condition: Male and female subjects with multiple sclerosis who have completed natalizumab studies C-1801, C-1802, or C-1803
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2005-004061-41 Sponsor Protocol Number: 101-MS-321 Start Date*: 2006-06-01
    Sponsor Name:BIOGEN IDEC LTD
    Full Title: An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 o...
    Medical condition: Multiple sclerosis (MS)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) BE (Prematurely Ended) FI (Prematurely Ended) IE (Prematurely Ended) DE (Prematurely Ended) AT (Prematurely Ended) SE (Prematurely Ended) HU (Prematurely Ended) DK (Prematurely Ended) CZ (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended) GR (Completed)
    Trial results: View results
    EudraCT Number: 2004-004130-14 Sponsor Protocol Number: IMA 04001 Start Date*: 2005-02-17
    Sponsor Name:Biogen Idec GmbH
    Full Title: A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with r...
    Medical condition: Male and female subjects with relapsing multiple sclerosis previously treated with interferon beta-1a (22 mcg or 44 mcg, SC three times a week).
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-017490-38 Sponsor Protocol Number: 101MS205 Start Date*: 2010-05-03
    Sponsor Name:Biogen Idec
    Full Title: Randomized Treatment Interruption of Natalizumab
    Medical condition: Natalizumab is a highly efficacious therapy used in the treatment of patients with relapsing multiple sclerosis (MS). This is a prospective randomized study in subjects with relapsing forms of MS w...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10063399 Relapsing-remitting multiple sclerosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-001442-15 Sponsor Protocol Number: CFTY720D2324 Start Date*: 2011-08-26
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from...
    Medical condition: relapsing remitting multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (Completed) ES (Completed) GR (Prematurely Ended) AT (Prematurely Ended) CZ (Completed) FI (Prematurely Ended) HU (Completed) SE (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-005082-13 Sponsor Protocol Number: 101MS328 Start Date*: 2013-04-02
    Sponsor Name:Biogen Idec Research Limited
    Full Title: A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple Scle...
    Medical condition: Relapsing Remitting Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-004616-21 Sponsor Protocol Number: CFTY720D2415T Start Date*: 2014-03-13
    Sponsor Name:Universitätsklinikum Münster
    Full Title: A 32-week, monocentric, exploratory, single arm study to assess immune function and MRI disease activity in patients with relapsing remitting multiple sclerosis (RRMS) transferred from previous tre...
    Medical condition: relapsing remitting multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-001514-15 Sponsor Protocol Number: 101SK201 Start Date*: 2013-11-26
    Sponsor Name:Biogen Idec Research Limited
    Full Title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) on Reducing Infarct Volume in Acute Ischem...
    Medical condition: Acute Ischemic Stroke
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004852 10055221 Ischemic stroke LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-004783-11 Sponsor Protocol Number: 101SK202 Start Date*: 2016-04-26
    Sponsor Name:Biogen Idec Research Limited
    Full Title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) in Acute Ischemic Stroke
    Medical condition: Acute Ischemic Stroke
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004852 10055221 Ischemic stroke LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-009503-19 Sponsor Protocol Number: TYS-IMA-08-11 Start Date*: 2010-07-20
    Sponsor Name:Biogen Idec International GmbH
    Full Title: A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients.
    Medical condition: Multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10063399 Relapsing-remitting multiple sclerosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-020369-26 Sponsor Protocol Number: 101JC404 Start Date*: 2010-11-29
    Sponsor Name:Biogen Idec
    Full Title: High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab
    Medical condition: Immune Reconstitution Inflammatory Syndrome
    Disease: Version SOC Term Classification Code Term Level
    12.1 10054014 Immune reconstitution syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-003669-97 Sponsor Protocol Number: BEL-TYS-14-10675 Start Date*: 2014-10-27
    Sponsor Name:Biogen Idec
    Full Title: A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA.
    Medical condition: Relapsing Forms of Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029205 - Nervous system disorders 10048393 Multiple sclerosis relapse PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-024000-10 Sponsor Protocol Number: 101MS206 Start Date*: 2011-06-28
    Sponsor Name:Biogen Idec Limited
    Full Title: A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis
    Medical condition: Relapsing-Remitting Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) ES (Completed) IT (Completed)
    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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