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Clinical trials for Monotherapy

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    2,108 result(s) found for: Monotherapy. Displaying page 1 of 106.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2018-001364-27 Sponsor Protocol Number: ZN-c5-001 Start Date*: Information not available in EudraCT
    Sponsor Name:Zeno Alpha, Inc.,
    Full Title: A PHASE 1/2 OPEN LABEL, MULTICENTER STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI-TUMOR ACTIVITY OF ZN-C5 ALONE AND IN COMBINATION WITH PALBOCICLIB IN SUBJECTS WITH ESTROGEN-...
    Medical condition: Estrogen-receptor positive, human epidermal growth factor receptor-2 negative advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed) LT (Ongoing) BG (Prematurely Ended) HU (Completed)
    Trial results: View results
    EudraCT Number: 2015-004477-32 Sponsor Protocol Number: CAIN457F2366 Start Date*: 2017-03-29
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, double-blind, active control, multicenter study to evaluate the efficacy at week 52 of subcutaneously administered secukinumab monotherapy compared with subcutaneously administered ad...
    Medical condition: Psoriatic Arthritis
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004859 10037160 Psoriatic arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) AT (Completed) GB (Completed) ES (Completed) GR (Completed) SK (Completed) DK (Completed) FI (Completed) NL (Completed) CZ (Completed) PT (Completed) HU (Completed) IS (Completed) BG (Completed) LT (Completed) LV (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-001580-37 Sponsor Protocol Number: EMPTRA-PTDM Start Date*: 2016-11-04
    Sponsor Name:Medical University of Vienna
    Full Title: Empagliflozin in Post-Transplantation Diabetes Mellitus
    Medical condition: Post-Transplant Diabetes Mellitus
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-005838-22 Sponsor Protocol Number: CLIO Start Date*: 2016-07-22
    Sponsor Name:UZLeuven
    Full Title: Circulating tumor DNA guiding (Olaparib) Lynparza® treatment in Ovarian Cancer (CLIO). Establishing the value of a ctDNA-based HRD assay for predicting olaparib response in women with relapsed ovar...
    Medical condition: platinum-sensitive and platinum-resistant relapsed ovarian cancer
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003127-11 Sponsor Protocol Number: CQVA149A3401 Start Date*: 2014-02-26
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A prospective, multicenter, 12-week, randomized open-label study to evaluate the efficacy and safety of glycopyrronium (50 micrograms o.d.) or indacaterol maleate and glycopyrronium bromide fixed-d...
    Medical condition: Chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) LT (Completed) SK (Completed) BE (Completed) EE (Completed) LV (Completed) IE (Completed) SE (Completed) AT (Completed) PT (Completed) IT (Completed) GB (Completed) DK (Completed) GR (Completed) HU (Completed) PL (Completed) ES (Completed) DE (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2011-001635-23 Sponsor Protocol Number: TMC114IFD3003 Start Date*: 2012-01-17
    Sponsor Name:Janssen Cilag International N.V.
    Full Title: PROTEAse inhibitor (DRV/rtv) in mono- or triple therapy in suppressed HIV-1 infected subjects
    Medical condition: HIV-1 infection
    Disease: Version SOC Term Classification Code Term Level
    15.0 100000004862 10020192 HIV-1 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) IE (Completed) DE (Completed) ES (Completed) AT (Completed) HU (Completed) DK (Completed) IT (Completed) SE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-003310-14 Sponsor Protocol Number: SHO20190708 Start Date*: 2019-12-05
    Sponsor Name:Department of Dermatology, Bispebjerg Hospital
    Full Title: Laser immunotherapy with and without topical anti-PD1 in basal cell carcinomas
    Medical condition: Basal cell carcinoma in 24-30 patients
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2012-002324-32 Sponsor Protocol Number: I4V-MC-JADZ Start Date*: 2013-02-25
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who H...
    Medical condition: Moderately to severely active rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) SE (Completed) DE (Completed) GB (Completed) PT (Completed) AT (Completed) IT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2014-005454-19 Sponsor Protocol Number: 51858 Start Date*: 2015-03-16
    Sponsor Name:Erasmus MC
    Full Title: The Dolutegravir Antiretroviral Mono-Therapy for HIV Trial
    Medical condition: Evaluation of the efficacy and safety of a switch from cART to dolutegravir monotherapy in HIV
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-001180-20 Sponsor Protocol Number: E2007-G000-410 Start Date*: 2021-10-28
    Sponsor Name:Eisai Inc.
    Full Title: Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Genera...
    Medical condition: Epilepsy: Partial Onset Seizures with or without 1) Secondarily Generalized Seizures 2) Primary Generalized Tonic-Clonic Seizures
    Disease: Version SOC Term Classification Code Term Level
    24.0 10029205 - Nervous system disorders 10085326 Parietal lobe epilepsy PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-004104-31 Sponsor Protocol Number: CSPP100F2301 Start Date*: 2009-03-13
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy compar...
    Medical condition: Chronic heart failure (NYHA Class II - IV)
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004849 10008908 Chronic heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) SK (Completed) NL (Completed) FI (Completed) SE (Completed) DK (Completed) LT (Completed) BE (Completed) PT (Completed) IT (Completed) IE (Completed) ES (Completed) CZ (Completed) PL (Completed) FR (Completed) LV (Completed) GB (Completed) EE (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2021-001641-13 Sponsor Protocol Number: CA224-098 Start Date*: 2022-01-11
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab +Relatlimab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma
    Medical condition: participants with completely resected Stage III or Stage IV melanoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025671 Malignant melanoma stage IV PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025670 Malignant melanoma stage III PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned) BE (Ongoing) FR (Trial now transitioned) CZ (Trial now transitioned) DK (Trial now transitioned) SE (Trial now transitioned) NO (Trial now transitioned) FI (Trial now transitioned) ES (Ongoing) IT (Ongoing) GR (Trial now transitioned) PT (Ongoing) Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2022-003061-38 Sponsor Protocol Number: NL82555.100.22 Start Date*: 2023-05-02
    Sponsor Name:Sint Antonius Ziekenhuis
    Full Title: Genotype-gUIded cLopidogrel monoTherapY (POPular GUILTY)
    Medical condition: Non-ST elevation acute coronary syndrome (coronary artery disease)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-003218-36 Sponsor Protocol Number: 82646 Start Date*: 2023-06-05
    Sponsor Name:Radboudumc
    Full Title: The safety of ticagrelor monotherapy after primary percutaneous coronary intervention for ST-elevation myocardial infarction and the effect on intramyocardial haemorrhage
    Medical condition: Acute myocardial infarction
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003334-27 Sponsor Protocol Number: M13-545 Start Date*: 2015-12-11
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumato...
    Medical condition: Moderately to Severely Active Rheumatoid Arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) SI (Completed) ES (Ongoing) GR (Completed) LT (Completed) BE (Completed) CZ (Completed) IE (Completed) LV (Completed) PL (Completed) GB (GB - no longer in EU/EEA) PT (Completed) HU (Completed) FI (Prematurely Ended) RO (Ongoing) HR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2007-005440-25 Sponsor Protocol Number: SP904 Start Date*: 2009-02-16
    Sponsor Name:UCB BIOSCIENCES, Inc.
    Full Title: A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-onset Seizures
    Medical condition: Partial-onset seizures (with and without secondary generalization)
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029205 - Nervous system disorders 10010145 Complex partial seizures PT
    16.1 10029205 - Nervous system disorders 10040703 Simple partial seizures PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) ES (Completed) AT (Completed) DK (Completed) PT (Not Authorised) IT (Completed) FR (Completed) DE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-003812-31 Sponsor Protocol Number: 182005 Start Date*: 2006-07-27
    Sponsor Name:Abteilung Klinische Chemie, UKL Freiburg
    Full Title: Niaspan in combination with fluvastatin compared to fluvastatin-monotherapy fpr patients with metabolic syndrome
    Medical condition: metabolic syndrome
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-004051-20 Sponsor Protocol Number: FER-TOC-2013-01 Start Date*: 2014-02-26
    Sponsor Name:FUNDACIÓN ESPAÑOLA DE REUMATOLOGIA
    Full Title: NOT CONTROLLED STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN PATIENTS WITH MODERATE OR SEVERE RHEUMATOID ARTHRITIS WHO ARE CANDIDATES TO BE TREATED WITH A BIOLOGICAL THERAPY AS MONOTHERAPY
    Medical condition: RHEUMATOID ARTHRITIS
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2007-003913-15 Sponsor Protocol Number: ANTRAG01 Start Date*: Information not available in EudraCT
    Sponsor Name:Medical University Innsbruck
    Full Title: Wirkung von Oxcarbazepin (Trileptal) auf den Kortikosteroid-Metabolismus - Pilotstudie
    Medical condition: Oxcarbazepin, a widely-used antiepileptic treatment is evaluated with respect to Cortisol-degradation. Young adults and adults with oxcarbazepine monotherapy since at least 6 months and temporal lo...
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2010-018580-42 Sponsor Protocol Number: PXL008-002 Start Date*: 2010-06-11
    Sponsor Name:Poxel
    Full Title: Randomized, double-blind, placebo-controlled, parallel-group study of the safety and efficacy of imeglimin or placebo add-on therapy in type 2 diabetic subjects not adequately controlled by metform...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    12.1 10012607 Diabetes mellitus inadequate control LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) HU (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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