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Clinical trials for Manual communication

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   44336   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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    20 result(s) found for: Manual communication. Displaying page 1 of 1.
    EudraCT Number: 2021-000070-29 Sponsor Protocol Number: 74668 Start Date*: 2022-09-15
    Sponsor Name:VU University Medical Center
    Full Title: A Proof-of-Concept Study to Explore the Potential Efficacy of Deferiprone in Patients With Pelizaeus-Merzbacher disease (PMD)
    Medical condition: Pelizaeus-Merzbacher disease
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003524-20 Sponsor Protocol Number: BP41316 Start Date*: 2020-12-15
    Sponsor Name:F. HOFFMANN - LA ROCHE LTD.
    Full Title: A phase II multicenter, randomized, double-blind, 12-week treatment, 3-arm, parallel-group, placebo-controlled study to investigate the efficacy, safety and tolerability of RO7017773 in participant...
    Medical condition: Autism Spectrum Disorder (ASD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10037175 Psychiatric disorders SOC
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-003775-39 Sponsor Protocol Number: F1D-MC_X311 Start Date*: 2008-10-29
    Sponsor Name:Charité – Universitätsmedizin Berlin
    Full Title: Randomised, placebo-controlled parallel-group trial to evaluate an oral dose of 10 mg Olanzapin combined with Riluzol for the treatment of appetite loss on patients with amyotrophic lateral sklerosis
    Medical condition: patients with amyotrophic lateral sclerosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-003870-21 Sponsor Protocol Number: MG0020 Start Date*: 2023-07-25
    Sponsor Name:UCB Biopharma SRL
    Full Title: An open-label, crossover study to evaluate rozanolixizumab self-administration by study participants with generalized Myasthenia Gravis
    Medical condition: Generalized Myasthenia Gravis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10028417 Myasthenia gravis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2020-003173-22 Sponsor Protocol Number: BP30153 Start Date*: 2020-11-12
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A Phase II Multi-Center, Randomized, Double-Blind, 24-Week, Parallel Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Children and Adolescents Age...
    Medical condition: Autism Spectrum Disorder
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001438-25 Sponsor Protocol Number: VWM1 Start Date*: 2020-04-21
    Sponsor Name:VU University Medical Center
    Full Title: A Study to Explore the Safety, Tolerability, Pharmacokinetic Profile, and Potential Efficacy of Guanabenz in Patients With Early Childhood Onset Vanishing White Matter (VWM)
    Medical condition: Vanishing white matter
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001333-38 Sponsor Protocol Number: CAVES Start Date*: 2021-10-05
    Sponsor Name:Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)
    Full Title: Cognitive effects of adjuntive Vortioxetine in early Schizophrenia
    Medical condition: Early schizophrenia
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-003265-34 Sponsor Protocol Number: MS200647_0005 Start Date*: 2019-06-04
    Sponsor Name:Merck KGaA
    Full Title: A Multicenter, Double Blind, Randomized, Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participa...
    Medical condition: Unresectable Stage III Non-small Cell Lung Cancer
    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
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) BE (Completed) NL (Completed) ES (Prematurely Ended) HU (Prematurely Ended) NO (Completed)
    Trial results: View results
    EudraCT Number: 2017-004378-32 Sponsor Protocol Number: WN39434 Start Date*: 2018-09-26
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A phase III, randomized, double-blind, placebo-controlled, efficacy, and safety study of Balovaptan in adults with Autism Spectrum Disorder with a 2 year open-label extension.
    Medical condition: Autism Spectrum Disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10063844 Autism spectrum disorder PT
    20.0 10037175 - Psychiatric disorders 10003805 Autism LLT
    21.1 10037175 - Psychiatric disorders 10034739 Pervasive developmental disorder NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-004594-32 Sponsor Protocol Number: IO102-IO103-013/MK3475-D18 Start Date*: 2022-02-16
    Sponsor Name:IO Biotech ApS
    Full Title: An open-label, randomized, Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable, or metastatic (adv...
    Medical condition: Patients with previously untreated, unresectable or metastatic (advanced) melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DK (Trial now transitioned) DE (Trial now transitioned) CZ (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) IE (Prematurely Ended) BE (Trial now transitioned) HU (Trial now transitioned) PT (Completed) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000063-88 Sponsor Protocol Number: RAP-MD-31 Start Date*: 2019-03-27
    Sponsor Name:Allergan Ltd.
    Full Title: A Randomized, Double-blind, Placebo- and Active- controlled, Multicenter Study of Rapastinel as Monotherapy in Major Depressive Disorder
    Medical condition: Major depressive disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-003583-40 Sponsor Protocol Number: MS200647_0017 Start Date*: 2020-07-07
    Sponsor Name:Merck Healthcare KGaA
    Full Title: A Phase II, Multicenter, Open Label Study of Bintrafusp alfa (M7824) Monotherapy in Participants with Advanced, Unresectable Cervical Cancer with Disease Progression During or After Platinum-Contai...
    Medical condition: Cervical Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10008229 Cervical cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Completed) ES (Ongoing) HU (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2023-001104-33 Sponsor Protocol Number: AT0071002 Start Date*: 2023-12-22
    Sponsor Name:Applied Therapeutics Inc.
    Full Title: A Sequential, Two-Part Study to Evaluate the Clinical Benefit, Safety, Pharmacokinetics, and Pharmacodynamics of AT-007 in Pediatric Patients with Classic Galactosemia (CG)
    Medical condition: Galactosemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10017610 Galactosemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2021-005530-42 Sponsor Protocol Number: imPaCT-PRO-01 Start Date*: 2021-12-07
    Sponsor Name:Institute of Molecular Medicine and Biomedical Research (IMBE)
    Full Title: The impact of Thromboprophylaxis on Progression Free Survival of Patients with Advanced Pancreatic Cancer. The Pancreatic Cancer & Tinzaparin Prospective (imPaCT-PRO) study
    Medical condition: Thromboprophylaxis in patients with advanced pancreatic cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10047065 - Vascular disorders 10043607 Thrombosis PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068067 Tumour thrombosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004040-29 Sponsor Protocol Number: CY5031 Start Date*: Information not available in EudraCT
    Sponsor Name:Cytokinetics Inc
    Full Title: A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS).
    Medical condition: Amyotrophic Lateral Sclerosis (ALS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10002026 Amyotrophic lateral sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IE (Prematurely Ended) FR (Prematurely Ended) PT (Prematurely Ended) BE (Prematurely Ended) SE (Prematurely Ended) ES (Prematurely Ended) PL (Prematurely Ended) IT (Prematurely Ended) NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-000714-37 Sponsor Protocol Number: MK-3475-799 Start Date*: 2018-11-05
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2 Trial of Pembrolizumab (MK-3475) in Combination with Platinum Doublet Chemotherapy and Radiotherapy for Participants with Unresectable, Locally Advanced Stage III Non-Small Cell Lung Canc...
    Medical condition: Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029519 Non-small cell lung cancer stage III PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Completed) FR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2008-007482-23 Sponsor Protocol Number: D1050235 Start Date*: 2009-10-21
    Sponsor Name:Sunovion Pharmaceuticals, Inc.
    Full Title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression
    Medical condition: Bipolar depression
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10004936 Bipolar depression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-003876-29 Sponsor Protocol Number: GMPO-131-002 Start Date*: 2017-05-16
    Sponsor Name:Orphalan
    Full Title: CHELATE STUDY: Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s disease
    Medical condition: Wilson's disease (WD) is a life-threatening inborn error of copper metabolism leading to an excessive copper accumulation, mainly in the liver or brain, causing hepatic and neurologic severe symptoms.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10047988 Wilson's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) DE (Completed) GB (GB - no longer in EU/EEA) AT (Completed) IT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-001992-35 Sponsor Protocol Number: MS200647_0055 Start Date*: 2020-04-30
    Sponsor Name:Merck Healthcare KGaA
    Full Title: A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp alfa (M7824) as First-line Treatment of Biliary Tract Cancer
    Medical condition: Biliary Tract Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028982 Neoplasm biliary tract LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073077 Intrahepatic cholangiocarcinoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074879 Extrahepatic cholangiocarcinoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017614 Gallbladder cancer PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10034442 Periampullary carcinoma metastatic LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10034443 Periampullary carcinoma non-resectable LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10034445 Periampullary carcinoma recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Prematurely Ended) PL (Completed) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-003707-19 Sponsor Protocol Number: MS200647_0047 Start Date*: 2019-04-15
    Sponsor Name:Merck KGaA
    Full Title: A Phase II, Multicenter, Open label Study to Investigate the Clinical Efficacy of M7824 Monotherapy in Participants With Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or are Intolera...
    Medical condition: Biliary Tract Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028982 Neoplasm biliary tract LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073077 Intrahepatic cholangiocarcinoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074879 Extrahepatic cholangiocarcinoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017614 Gallbladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) IT (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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