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Clinical trials for Digital therapeutics

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   44335   clinical trials with a EudraCT protocol, of which   7366   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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    16 result(s) found for: Digital therapeutics. Displaying page 1 of 1.
    EudraCT Number: 2008-005018-39 Sponsor Protocol Number: TDE-DU-201 Start Date*: 2009-03-05
    Sponsor Name:United Therapeutics Corporation
    Full Title: DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study
    Medical condition: Systemic Sclerosis, scleroderma digital ulcers
    Disease: Version SOC Term Classification Code Term Level
    9.1 10042953 Systemic sclerosis LLT
    9.1 10039710 Scleroderma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-004744-31 Sponsor Protocol Number: TR12 Start Date*: 2019-06-24
    Sponsor Name:Trevi Therapeutics, Inc.
    Full Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Two-Treatment, Two-Period Crossover Efficacy and Safety Study in Idiopathic Pulmonary Fibrosis With Nalbuphine ER Tablets for the Treatment ...
    Medical condition: Treatment of Cough in Idiopathic Pulmonary Fibrosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2008-006978-15 Sponsor Protocol Number: TDE-DU-202 Start Date*: 2009-03-05
    Sponsor Name:United Therapeutics Corporation
    Full Title: DISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study
    Medical condition: Systemic Sclerosis, scleroderma digital ulcers
    Disease: Version SOC Term Classification Code Term Level
    14.0 10028395 - Musculoskeletal and connective tissue disorders 10039710 Scleroderma PT
    14.0 10028395 - Musculoskeletal and connective tissue disorders 10042953 Systemic sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-004979-37 Sponsor Protocol Number: 06-004 Start Date*: 2006-10-27
    Sponsor Name:MediQuest Therapeutics, Inc.
    Full Title: Phase III “In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon
    Medical condition: Moderate to severe primary Raynaud’s, OR patients with Raynaud’s phenomenon secondary to autoimmune diseases, such as scleroderma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-000831-21 Sponsor Protocol Number: HZNP-DAX-202 Start Date*: 2023-02-06
    Sponsor Name:Horizon Therapeutics Ireland DAC
    Full Title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP TRIAL TO INVESTIGATE THE EFFICACY AND SAFETY OF DAXDILIMAB SUBCUTANEOUS INJECTION IN REDUCING DISEASE ACTIVITY I...
    Medical condition: Discoid Lupus Erythematosus
    Disease: Version SOC Term Classification Code Term Level
    25.0 100000004858 10013072 Discoid lupus erythematosus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) BG (Trial now transitioned) PL (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-006794-37 Sponsor Protocol Number: VRDN-001-101 Start Date*: 2022-05-20
    Sponsor Name:Viridian Therapeutics, Inc.
    Full Title: A multiple ascending dose (MAD) safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in normal healthy volunteers (NHVs) and sub...
    Medical condition: Thyroid eye disease (TED)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004853 10084358 Thyroid eye disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) NL (Trial now transitioned) IT (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004806-17 Sponsor Protocol Number: PQ-313-002 Start Date*: 2018-05-18
    Sponsor Name:Wings Therapeutics Inc.
    Full Title: A first in human, double-blind, randomized, intra-subject placebo-controlled, multiple dose study of QR-313 evaluating safety, proof of mechanism, preliminary efficacy and systemic exposure in subj...
    Medical condition: Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 gene
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10014989 Epidermolysis bullosa PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Prematurely Ended) DE (Prematurely Ended) CZ (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-004983-39 Sponsor Protocol Number: RX-3341-303 Start Date*: 2015-01-26
    Sponsor Name:Melinta Therapeutics, Inc
    Full Title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF IV AND ORAL DELAFLOXACIN COMPARED WITH VANCOMYCIN + AZTREONAM IN PATIENTS WITH ACUTE...
    Medical condition: ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) EE (Completed) LV (Completed) SK (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2019-002952-17 Sponsor Protocol Number: CVL-751-PD-004 Start Date*: 2021-03-30
    Sponsor Name:Cerevel Therapeutics, LLC
    Full Title: 58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial)
    Medical condition: Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned) BG (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-001377-31 Sponsor Protocol Number: HZNP-DAX-203 Start Date*: 2022-12-09
    Sponsor Name:Horizon Therapeutics Ireland DAC
    Full Title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY EVALUATING THE EFFICACY AND SAFETY OF DAXDILIMAB IN ADULT PARTICIPANTS WITH ACTIVE PROLIFERATIVE LUPUS NEPHRITIS
    Medical condition: ACTIVE PROLIFERATIVE LUPUS NEPHRITIS
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10025140 Lupus nephritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) HR (Completed)
    Trial results: View results
    EudraCT Number: 2019-002098-68 Sponsor Protocol Number: BBTAF202 Start Date*: 2020-02-04
    Sponsor Name:Blueberry Therapeutics Ltd
    Full Title: A Multi-Centre, International, Randomised, Vehicle Controlled, Parallel-Group, Double-Blinded Phase 2 Trial of BB2603 Topical Treatment in Subjects with Distal Subungual Onychomycosis (DSO) of the...
    Medical condition: Distal Subungual Onychomycosis (DSO) of the Toenail
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10030338 Onychomycosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-006271-42 Sponsor Protocol Number: HZNP-HZN-825-302 Start Date*: 2022-12-15
    Sponsor Name:Horizon Therapeutics Ireland DAC
    Full Title: A Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis
    Medical condition: Diffuse Cutaneous Systemic Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004859 10042953 Systemic sclerosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) GR (Trial now transitioned) IT (Trial now transitioned) DE (Trial now transitioned) AT (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) PT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-001767-71 Sponsor Protocol Number: RX-3341-302 Start Date*: 2013-06-20
    Sponsor Name:Melinta Therapeutics, Inc
    Full Title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, ACTIVE CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DELAFLOXACIN COMPARED WITH VANCOMYCIN + AZTREONAM IN PATIENTS WITH ACUTE BACTERIAL S...
    Medical condition: ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LV (Completed) ES (Completed) BG (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2011-005040-10 Sponsor Protocol Number: PRO045-CLIN-01 Start Date*: 2012-12-03
    Sponsor Name:BioMarin Nederland B.V.
    Full Title: A phase IIb, open-label study to assess the efficacy, safety, pharmacodynamics and pharmacokinetics of multiple subcutaneous doses of PRO045 in subjects with Duchenne muscular dystrophy
    Medical condition: Duchenne muscular dystrophy resulting from a mutation correctable by PRO045-induced DMD exon 45 skipping
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: BE (Completed) GB (Completed) IT (Prematurely Ended) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-020825-42 Sponsor Protocol Number: RTOG0815 Start Date*: 2010-11-08
    Sponsor Name:Radiation Therapy Oncology Group
    Full Title: A PHASE III PROSPECTIVE RANDOMIZED TRIAL OF DOSE-ESCALATED RADIOTHERAPY WITH OR WITHOUT SHORT-TERM ANDROGEN DEPRIVATION THERAPY FOR PATIENTS WITH INTERMEDIATE-RISK PROSTATE CANCER
    Medical condition: intermediate risk prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    12.1 10026389 Malignant neoplasm of prostate LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005042-35 Sponsor Protocol Number: PRO053-CLIN-01 Start Date*: 2013-08-23
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase I/II, open-label, dose escalating with 48 week treatment study to assess the safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of BMN 053 (previously known as PRO053)...
    Medical condition: Duchenne muscular dystrophy resulting from a mutation correctable by BMN 053-induced DMD exon 53 skipping
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (Prematurely Ended) BE (Completed) IT (Prematurely Ended) NL (Prematurely Ended) FR (Ongoing)
    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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