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Clinical trials for Case report form

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   44334   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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    242 result(s) found for: Case report form. Displaying page 7 of 13.
    EudraCT Number: 2022-001654-38 Sponsor Protocol Number: TAK-861-2001 Start Date*: 2023-05-26
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
    Medical condition: Narcolepsy with cataplexy (Narcolepsy Type 1)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NO (Completed) FI (Completed) SE (Completed) NL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2007-004482-18 Sponsor Protocol Number: R076477-SCH-4013 Start Date*: 2008-01-03
    Sponsor Name:Ortho-McNeil Janssen Scientific Affairs, LLC
    Full Title: A blinded-initiation study of medication satisfaction in subjects with schizophrenia treated with paliperidone ER after suboptimal response to oral risperidone.
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039626 Schizophrenia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2007-005905-23 Sponsor Protocol Number: M10-261 Start Date*: 2008-05-13
    Sponsor Name:Abbott GmbH & Co. KG
    Full Title: A Multi-center, Randomized, Double-blind, Placebo − controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared Wi...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2022-001087-10 Sponsor Protocol Number: ELA-0121 Start Date*: 2022-11-21
    Sponsor Name:Stemline Therapeutics, Inc
    Full Title: An Open-label Multicenter Phase 1b-2 Study of Elacestrant as Monotherapy and in Combination with Abemaciclib in Women and Men with Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative B...
    Medical condition: Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-002227-13 Sponsor Protocol Number: ACP-103-045 Start Date*: 2018-02-04
    Sponsor Name:ACADIA Pharmaceuticals Inc.
    Full Title: A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis
    Medical condition: Hallucinations and Delusions Associated With Dementia-related Psychosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10012295 Dementia of the Alzheimer's type, with delusions PT
    20.0 100000004873 10019077 Hallucinations LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) CZ (Completed) SK (Prematurely Ended) BG (Completed) ES (Prematurely Ended) PL (Prematurely Ended) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-005510-34 Sponsor Protocol Number: MMV_DSM265_14_01 Start Date*: 2015-09-30
    Sponsor Name:Medicines for Malaria Venture
    Full Title: Evaluation of the prophylactic antimalarial activity of a single dose of DSM265 in non-immune healthy adult volunteers by controlled human malaria infection with PfSPZ Challenge
    Medical condition: Healthy volunteers; controlled human malaria infection with PfSPZ
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10025494 Malaria prophylaxis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004367-20 Sponsor Protocol Number: MET54 Start Date*: 2015-03-16
    Sponsor Name:Sanofi Pasteur
    Full Title: A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccines in Healthy Toddlers
    Medical condition: Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10058858 Meningococcal bacteraemia PT
    18.0 10021881 - Infections and infestations 10027274 Meningococcal infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2011-000385-35 Sponsor Protocol Number: RA0069 Start Date*: 2011-08-19
    Sponsor Name:UCB PHARMA
    Full Title: MULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEU...
    Medical condition: 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 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-003267-55 Sponsor Protocol Number: A3L45 Start Date*: 2015-09-03
    Sponsor Name:Sanofi Pasteur SA
    Full Title: An international, multicenter, open-label, one-arm study in 150 infants vaccinated with a 3-dose primary series of the DTaP-IPV-Hep B-PRP-T combined vaccine in the Russian Federation and Poland.
    Medical condition: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus in...
    Disease: Version SOC Term Classification Code Term Level
    18.0 10042613 - Surgical and medical procedures 10036897 Prophylactic vaccination LLT
    18.0 10042613 - Surgical and medical procedures 10043413 Therapeutic procedures and supportive care NEC HLGT
    18.0 10042613 - Surgical and medical procedures 10021430 Immunisation PT
    18.0 10042613 - Surgical and medical procedures 10021431 Immunisations HLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2022-002452-40 Sponsor Protocol Number: Td500056 Start Date*: 2023-03-08
    Sponsor Name:Sanofi Pasteur
    Full Title: Immune Response to Pertussis after Vaccination with a Tdap-IPV Booster Vaccine in Children in the Republic of South Africa: Effect of Homologous and Heterologous Pertussis Vaccination Priming Backg...
    Medical condition: Bacterial infections
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10069577 Pertussis immunisation PT
    21.1 10042613 - Surgical and medical procedures 10054129 Diphtheria immunisation PT
    21.1 10042613 - Surgical and medical procedures 10054131 Tetanus immunisation PT
    21.1 10042613 - Surgical and medical procedures 10053386 Poliomyelitis vaccine LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-002498-36 Sponsor Protocol Number: CCN017 Start Date*: 2018-10-12
    Sponsor Name:National Institutes of Health - Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Full Title: Clinical Evaluation of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception
    Medical condition: As the clinical trial is intended to investigate a new contraceptive medicinal product, the trial subjects included are not characterized by a specific medical condition.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10065589 Male contraception PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-015579-28 Sponsor Protocol Number: FER-CKD-01 Start Date*: 2009-12-22
    Sponsor Name:Vifor Pharma Inc.
    Full Title: An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject® High- and Low-dosage Regimens) versus Oral Ir...
    Medical condition: Iron deficiency anaemia in subjects with non-dialysis-dependent chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    14.0 10005329 - Blood and lymphatic system disorders 10022972 Iron deficiency anaemia PT
    14.0 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) SE (Completed) FR (Completed) DE (Completed) DK (Completed) ES (Completed) IT (Completed) CZ (Completed) AT (Completed) GR (Completed) PT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-001132-22 Sponsor Protocol Number: BGB-A317-NSCL-001 Start Date*: 2019-05-20
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 3, Randomized, Blinded, Placebo-controlled Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects with Locally A...
    Medical condition: non-small cell lung cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029519 Non-small cell lung cancer stage III PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025052 Lung cancer non-small cell stage III LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025054 Lung cancer non-small cell stage IIIB LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025053 Lung cancer non-small cell stage IIIA LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025061 Lung cancer stage III LLT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10080083 Advanced lung cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) ES (Prematurely Ended) FI (Prematurely Ended) PL (Completed) HU (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-021143-41 Sponsor Protocol Number: 31-10-270 Start Date*: 2010-12-22
    Sponsor Name:Otsuka Pharmaceutical Development and Commercialization, Inc.
    Full Title: An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients with Schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    17.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed) BG (Completed) SK (Completed) HU (Completed) EE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-001673-75 Sponsor Protocol Number: ABX464-401 Start Date*: 2020-05-06
    Sponsor Name:ABIVAX
    Full Title: A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing COVID-19 associated acute respiratory failu...
    Medical condition: COVID-19 infection (infection with SARS-CoV-2 virus)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) DE (Completed) GB (GB - no longer in EU/EEA) ES (Prematurely Ended) BE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000675-20 Sponsor Protocol Number: ISIS766720-CS5 Start Date*: 2020-11-04
    Sponsor Name:Ionis Pharmaceuticals, Inc.
    Full Title: An Open Label, Randomized, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of IONIS GHR-LRX, an Antisense Inhibitor of the Growth Hormone Receptor, Administered Monthly as Monotherap...
    Medical condition: Acromegaly is a chronic disorder caused by GH hypersecretion, most commonly as a result of a GH-secreting pituitary adenoma.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10000599 Acromegaly PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed) PL (Completed) LV (Prematurely Ended) IT (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2008-004764-39 Sponsor Protocol Number: CTBM100C2303E1 Start Date*: 2009-09-07
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Comp...
    Medical condition: Pseudomonas aeruginosa infection in cystic fibrosis patients
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 10021860 Infection pseudomonas aeruginosa LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: LT (Completed) LV (Completed) EE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2014-004567-21 Sponsor Protocol Number: 3119001 Start Date*: 2015-06-05
    Sponsor Name:Orion Corporation Orion Pharma
    Full Title: Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension
    Medical condition: Amyotrophic lateral sclerosis (ALS). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss ...
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029205 - Nervous system disorders 10002026 Amyotrophic lateral sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) DE (Completed) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-001835-35 Sponsor Protocol Number: 2014.TTRANSPORT Start Date*: 2015-03-30
    Sponsor Name:Fundación Santiago Dexeus Font (Dexeus)
    Full Title: Transdermal testosterone gel for poor ovarian responders. A multicenter double-blind placebo controlled randomized trial.
    Medical condition: Infertility in women with poor ovarian response to stimulation for IVF/ICSI
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038604 - Reproductive system and breast disorders 10021928 Infertility female PT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) ES (Prematurely Ended) DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-006538-16 Sponsor Protocol Number: A6181114 Start Date*: 2007-03-30
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017, US
    Full Title: AN OPEN-LABEL SUNITINIB MALATE (SU011248) CONTINUATION PROTOCOL FOR PATIENTS WHO HAVE COMPLETED A PRIOR SUNITINIB STUDY AND ARE JUDGED BY THE INVESTIGATOR TO HAVE THE POTENTIAL TO BENEFIT FROM SUNI...
    Medical condition: Malignant Gastrointestinal Stromal Tumor (GIST), Metastatic Breast Cancer, Metastatic Renal Cell Cancer, Pancreatic Neuroendocrine Tumor, Hepatocellular Carcinoma, Prostate Cancer, Thyroid Cancer, ...
    Disease: Version SOC Term Classification Code Term Level
    15.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027655 Miscellaneous and site unspecified neoplasms malignant and unspecified HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) FR (Completed) DK (Prematurely Ended) GB (Completed) NL (Prematurely Ended) BG (Completed) ES (Completed)
    Trial results: View results
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    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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