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Clinical trials for Tetrahydrofolic acid

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 ).  
     
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    3 result(s) found for: Tetrahydrofolic acid. Displaying page 1 of 1.
    EudraCT Number: 2014-001862-84 Sponsor Protocol Number: ISO-CC-005 Start Date*: 2014-07-24
    Sponsor Name:Isofol Medical AB
    Full Title: An Open-label, Multiple-site, Phase I/II Dose Cohort Trial of [6R] 5,10-Methylene Tetrahydrofolate (Modufolin®) in Combination with a Fixed Dose of 5-Fluorouracil (5-FU) alone or together with a Fi...
    Medical condition: Advanced metastatic colorectal cancer (stage IV)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10010035 Colorectal cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) NO (Prematurely Ended) DK (Prematurely Ended) GR (Completed)
    Trial results: View results
    EudraCT Number: 2012-000522-22 Sponsor Protocol Number: ISO-CC-002 Start Date*: 2012-05-30
    Sponsor Name:Isofol Medical AB
    Full Title: A Single-blind, Randomized Phase I/II study of Pharmacokinetic and Pharmacodynamic investigation of Modufolin® (60 or 200 mg/m2) compared to Levoleucovorin (60 or 200 mg/m2) in tumour, adjacent muc...
    Medical condition: Colon cancer
    Disease: Version SOC Term Classification Code Term Level
    16.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009944 Colon cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2013-001280-23 Sponsor Protocol Number: ISO-MTX-003 Start Date*: 2013-09-19
    Sponsor Name:Isofol Medical AB
    Full Title: An Open-Label, Multicenter, Phase I/II Clinical Trial to Identify the Modufolin® Dose with Most Favorable Safety Prospect and Confirmed Ability to Mitigate High-Dose Methotrexate Induced Toxicity d...
    Medical condition: Rescue after High Dose Methotrexate therapy in Osteosarcoma patients.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10061814 Detoxification PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) HU (Completed) CZ (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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