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Clinical trials for Breakthrough therapy

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   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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    141 result(s) found for: Breakthrough therapy. Displaying page 1 of 8.
    1  2  3  4  5  6  7  8  Next»
    EudraCT Number: 2006-006678-12 Sponsor Protocol Number: 05ct149fe Start Date*: 2007-06-29
    Sponsor Name:Haupt Pharma Wolfratshausen GmbH
    Full Title: Nasal Transmucosal Fentanyl Citrate (NTFC) versus Oral Morphine Sulphate (OMS): A double-blind, double dummy, randomised, multi-centre, comparative cross-over study for the treatment of breakthroug...
    Medical condition: Cancer-related breakthrough pain
    Disease: Version SOC Term Classification Code Term Level
    12.1 10064556 Breakthrough pain LLT
    Population Age: Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-004608-17 Sponsor Protocol Number: SJ2021100 Start Date*: 2021-10-18
    Sponsor Name:AZ Sint-Jan Brugge-Oostende AV
    Full Title: Effectivity of a mRNA-1273 booster vaccine against Covid-19 breakthrough infections in hemodialysis patients: a multicenter interventional study
    Medical condition: hemodialysis patients
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-002544-25 Sponsor Protocol Number: CL_700_002_PRO-AME3 Start Date*: 2006-01-02
    Sponsor Name:LAB Pharma Ltd
    Full Title: A Multicentre, Multinational, Open-Label Trial (including Double-Blind, Placebo-Controlled Cross-Over Extension Part) to Evaluate the Time to Significant Pain Relief with Fentanyl TAIFUN® in the Tr...
    Medical condition: Patients with cancer having episodes of breakthrough pain
    Disease: Version SOC Term Classification Code Term Level
    7.1 10058019 canc
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-005393-31 Sponsor Protocol Number: CL_700_015_PRO Start Date*: 2008-08-25
    Sponsor Name:Akela Pharma Inc
    Full Title: A Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial to Evaluate Efficacy and Safety of Fentanyl TAIFUN® Treatment after Titrated Dose Administration for Bre...
    Medical condition: Breakthrough pain in opioid tolerant cancer patients.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended) CZ (Completed) HU (Completed) BG (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-007964-40 Sponsor Protocol Number: CL_700_018 Start Date*: 2009-02-27
    Sponsor Name:AKELA Pharma Inc.
    Full Title: A Multicenter, Multinational, Randomized, Open-Label, Parallel-Group 12-Week Trial to Evaluate the Safety of Fentanyl TAIFUN® Treatment after Titrated Dose Administration and the Current Breakthrou...
    Medical condition: Breakthrough pain in opioid tolerant cancer patients
    Disease: Version SOC Term Classification Code Term Level
    11.0 10064556 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-005403-34 Sponsor Protocol Number: CP045/06/FCNS Start Date*: 2007-02-01
    Sponsor Name:Archimedes Development Ltd
    Full Title: An open-label study investigating long-term safety and tolerability of Nasalfent (Fentanyl Citrate Nasal Spray) in the treatment of breakthrough cancer pain (BTCP) in subjects taking regular opioid...
    Medical condition: The treatment of Breakthrough Cancer Pain (BTCP) in subjects taking regular opioid therapy.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10058019 Cancer pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) DE (Completed) CZ (Completed) ES (Ongoing) FR (Completed) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-001620-21 Sponsor Protocol Number: CL_700_001_PRO Start Date*: 2004-11-23
    Sponsor Name:LAB Pharma Ltd
    Full Title: A multicentre, multinational, randomised, double blind, single dummy, parallel group, placebo-controlled trial to investigate the dose-response and safety of Fentanyl TAIFUN 100 µg, 200 µg, 400 µg ...
    Medical condition: Patients with cancer having episodes of breakthrough pain.
    Disease: Version SOC Term Classification Code Term Level
    7.1 10058019 canc
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) EE (Completed) LV (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-005382-35 Sponsor Protocol Number: CL_700_014_PRO Start Date*: 2008-08-18
    Sponsor Name:Akela Pharma Inc
    Full Title: A Multicenter, Multinational, Randomized, Open-Label, Parallel-Group Trial to Evaluate the Safety of Fentanyl TAIFUN® Treatment after Titrated Dose Administration and the Current Breakthrough Pain ...
    Medical condition: Breakthrough pain in opioid tolerant cancer patients.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-001841-24 Sponsor Protocol Number: C25608/4027/BP/EU Start Date*: 2008-08-04
    Sponsor Name:Cephalon France
    Full Title: A European Multicenter Open-label Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients
    Medical condition: Breakthrough Pain (BTP) in cancer patients
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064556 Breakthrough pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) NL (Completed) FR (Completed) IE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-003493-97 Sponsor Protocol Number: CP044/06/FCNS Start Date*: 2007-04-30
    Sponsor Name:Archimedes Development Ltd.
    Full Title: A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) Compared to Immediate Release Morphine Sulphate Tablets in the Treatment of Breakthr...
    Medical condition: Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy
    Disease: Version SOC Term Classification Code Term Level
    8.1 10058019 Cancer pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) FR (Ongoing) ES (Ongoing) IT (Ongoing) DE (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-002552-17 Sponsor Protocol Number: P-AD923-004 Start Date*: 2008-02-28
    Sponsor Name:Sosei R&D Ltd
    Full Title: A Multicentre, Randomised, Double-Blind, Double-Dummy, Crossover Study to Evaluate the Safety and Efficacy of AD 923 (Fentanyl Sublingual) in Comparison to Morphine Sulphate Immediate Release (MSIR...
    Medical condition: Cancer break-through pain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058019 Cancer pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-003172-39 Sponsor Protocol Number: Mica1/2012 Start Date*: 2013-05-23
    Sponsor Name:Medizinische Universität Innsbruck, Abteilung für Hygiene und Medizinische Mikrobiologie
    Full Title: Micafungin-Deescaltion study: Evalutating the rate of breakthrough infections of micafungin followed by fluconazole versus fluconazole (or other azoles) in febrile patients
    Medical condition: All patients who are suspicious of suffering from invasive fungal infections are included.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2007-000558-30 Sponsor Protocol Number: P-AD923-005 Start Date*: 2007-12-21
    Sponsor Name:Sosei R&D Ltd
    Full Title: A Multicentre, Randomised, Double-Blind, Double-Dummy, Crossover Study to Evaluate the Safety and Efficacy of AD 923 (Fentanyl Sublingual) in Comparison to Morphine Sulphate Immediate Release (MSIR...
    Medical condition: Cancer break-through pain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058019 Cancer pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) GB (Prematurely Ended) BE (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-003304-13 Sponsor Protocol Number: TAK-577-3001 Start Date*: Information not available in EudraCT
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis with rVWF in Children Diagnosed With Severe von Willebrand disease
    Medical condition: severe von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IE (Trial now transitioned) NO (Completed) SE (Prematurely Ended) ES (Trial now transitioned) FR (Trial now transitioned) AT (Prematurely Ended) NL (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001341-40 Sponsor Protocol Number: COMB157G23101 Start Date*: 2020-05-07
    Sponsor Name:Novartis Pharma AG
    Full Title: A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes(PRO) in patients with relapsing multiple sclerosis (RMS) transi...
    Medical condition: Multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10048393 Multiple sclerosis relapse PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Trial now transitioned) GR (Completed) HU (Completed) SK (Trial now transitioned) BE (Completed) PT (Trial now transitioned) BG (Trial now transitioned) ES (Ongoing) NO (Completed) AT (Completed) PL (Trial now transitioned) IT (Completed) SI (Trial now transitioned) LV (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-002800-40 Sponsor Protocol Number: A1501073 Start Date*: 2006-02-09
    Sponsor Name:Pfizer Ltd
    Full Title: Prospective, Open-label, Comparative, Multicenter Study of Voriconazole Compared to Itraconazole for the Primary Prophylaxis of Invasive Fungal Infections (IFI) in Subjects with Allogeneic Hematopo...
    Medical condition: Prophylaxis against invasive fungal infection following allogeneic hematopoietic stem cell transplantation.
    Disease: Version SOC Term Classification Code Term Level
    8 10017533
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) ES (Completed) PT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2008-007690-21 Sponsor Protocol Number: 42160443PAI2001 Start Date*: 2009-10-02
    Sponsor Name:Janssen Cilag International NV
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Cancer-Related Pain, Foll...
    Medical condition: Subjects with inadequately controlled, moderate to severe, chronic, cancer-related pain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058019 Cancer pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) ES (Completed) PT (Completed) IT (Completed) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-002557-56 Sponsor Protocol Number: ACT11705 Start Date*: 2011-11-24
    Sponsor Name:sanofi-aventis
    Full Title: A randomized, double-blind, parallel-group, placebo-controlled study to assess the clinical benefit of SSR411298 as adjunctive treatment for persistent cancer pain
    Medical condition: cancer pain
    Disease: Version SOC Term Classification Code Term Level
    14.1 10018065 - General disorders and administration site conditions 10069398 Breakthrough cancer pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) CZ (Prematurely Ended) HU (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-000944-43 Sponsor Protocol Number: GS-US-248-0120 Start Date*: 2011-08-09
    Sponsor Name:Gilead Sciences Inc.
    Full Title: A Phase 2 Randomized, Open-Label Study of GS-5885 Administered Concomitantly with GS-9451, Tegobuvir and Ribavirin (RBV) to Treatment-Naive Subjects with Chronic Genotype 1 HCV Infection
    Medical condition: Genotype 1 Hepatitis C Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    14.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-000245-39 Sponsor Protocol Number: LEG-SIL-2-01 Start Date*: 2013-09-11
    Sponsor Name:Rottapharm S.p.A
    Full Title: Rescue effect of daily infusions with Legalon® SIL in Hepatitis C Virus-infected patients who are incomplete responders to standard pegylated interferon/ribavirin (dual therapy) or pegylated interf...
    Medical condition: HCV infected patients who are incomplete responders to standard pegylated interferon/ribavirin (dual therapy) or pegylated interferon/ribavirin plus a protease inhibitor (triple therapy)
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004848 10066936 HCV viral load LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) AT (Prematurely Ended)
    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
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