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Clinical trials for Off-label use

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   44343   clinical trials with a EudraCT protocol, of which   7372   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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    62 result(s) found for: Off-label use. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2016-002859-19 Sponsor Protocol Number: 072016 Start Date*: 2017-08-22
    Sponsor Name:Erasmus MC
    Full Title: Withdrawing off-label antipsychotics in people with intellectual disabilities: why does it fail?
    Medical condition: People with challenging behavior and off-label antipsychotic use
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003718-10 Sponsor Protocol Number: 2014RISP-ID01 Start Date*: 2015-09-15
    Sponsor Name:UMCG
    Full Title: A placebo-controlled discontinuation trial of off-label used risperidone in people with intellectual disability
    Medical condition: no specific condition, we will investigate people with intellectual disability who have been using risperidone on an off-label basis for at least one year.
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-003651-54 Sponsor Protocol Number: 2014RISP1 Start Date*: 2015-10-14
    Sponsor Name:UMCG
    Full Title: ‘Off-label use of Risperidone in Children and Adolescents (ORCA): a double-blind placebo-controlled discontinuation trial’
    Medical condition: no specific condition, we will investigate children who have been using risperidone on an off-label basis for at least one year.
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005938-15 Sponsor Protocol Number: CloTASH-2021-2Version15.10.21 Start Date*: 2021-11-03
    Sponsor Name:Oslo University Hospital
    Full Title: Health risks and treatment of anabolic-androgenic steroid (AAS) induced hypogonadism among men – a pilot study exploring off-label use of clomiphene citrate to reduce symptoms of androgen deficienc...
    Medical condition: Anabolic androgenic steroid induced hypogonadism among men
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002011-61 Sponsor Protocol Number: 77267 Start Date*: 2021-08-13
    Sponsor Name:Academisch ziekenhuis Maastricht
    Full Title: The glutamate/GABA balance as novel therapeutic target for psychotic and cognitive symptoms in 22q11.2 deletion syndrome
    Medical condition: 22q11.2 deletion syndrome
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-000492-32 Sponsor Protocol Number: T16/2013 Start Date*: 2013-07-10
    Sponsor Name:Turku University Hospital
    Full Title: T cell and interferon expression in tonsils after sublingual immunotherapy and/or nasal live attenuated influenza vaccine
    Medical condition: We investigate the effects of allergen and virus on patients with recurrent tonsillitis or tonsillar hypertrphy.
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001560-35 Sponsor Protocol Number: 2358 Start Date*: 2016-04-07
    Sponsor Name:Brain Center Rudolf Magnus, University Medical Center Utrecht, Department of Psychiatry, Utrecht , the Netherlands
    Full Title: Bumetanide in Autism Medication and BIomarker study
    Medical condition: Autism Spectrum Disorder
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-004183-21 Sponsor Protocol Number: 2858 Start Date*: 2013-01-25
    Sponsor Name:North Bristol NHS Trust
    Full Title: A randomized, double blind, placebo controlled, cross over trial of Melatonin for the treatment of nocturia in adults with progressive multiple sclerosis, with an open label, single-arm extension s...
    Medical condition: Nocturia; Multiple Sclerosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002170-52 Sponsor Protocol Number: 66242 Start Date*: 2019-03-04
    Sponsor Name:VU University Medical Center (VUmc)
    Full Title: TrimetaziDine as a Performance-enhancING drug in Heart Failure with Preserved Ejection Fraction
    Medical condition: Heart failure with preserved ejection fraction (HFpEF)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    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: 2018-001191-38 Sponsor Protocol Number: TYKS/LeLiBu/1-2 Start Date*: 2020-03-03
    Sponsor Name:Turku University Hospital
    Full Title: Levobupivacaine versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis – Off-Label, Investigator Initiated Randomized, Controlled, Double-Blind Cross-...
    Medical condition: Lateral epicondylitis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002588-17 Sponsor Protocol Number: SAM-IIT01 Start Date*: 2019-10-21
    Sponsor Name:Universitätsklinikum Tübingen
    Full Title: Safety and effects on visual function of 0.01% Atropin eye drops for myopia inhibition in children and adolescents
    Medical condition: Myopia
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001703-37 Sponsor Protocol Number: D-FR-52120-244 Start Date*: 2018-09-06
    Sponsor Name:Ipsen Innovation SAS
    Full Title: A double-blind, randomised, placebo controlled, proof-of-concept study in subjects with abdominal or thoracic chronic scar pain to assess the analgesic properties of intradermal doses of Dysport®
    Medical condition: Post-Surgical neuralgia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10054095 Neuropathic pain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-004623-36 Sponsor Protocol Number: MEGALiT1901 Start Date*: 2019-11-29
    Sponsor Name:Uppsala University Hospital
    Full Title: A MolEcularly Guided Anti-Cancer Drug Off-Label Trial – a multicenter, basket and umbrella explorative trial on the efficacy and safety of molecular profile selected commercially available targete...
    Medical condition: In part 1 of the study: any solid tumor with the exemption of sarcoma. In part 2: any solid tumor or hematological malignancy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-004887-24 Sponsor Protocol Number: NBK182/1/2020 Start Date*: 2021-04-14
    Sponsor Name:Marcin Gruchała Medical University of Gdańsk
    Full Title: Dual Antithrombotic Therapy with Dabigatran and Ticagrelor in Patients with Acute Coronary Syndrome and Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ADONIS-PCI)
    Medical condition: Acute Coronary Syndrome and Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10051592 Acute coronary syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-004881-33 Sponsor Protocol Number: 73-05-3832-397285-12 Start Date*: 2017-02-28
    Sponsor Name:Universitätsklinikum Würzburg
    Full Title: Pharmacovigilance in children and adolescents: clinical trial protocol, subproject 1: Large Simple Trial, IIIb on the (off-label-) use of antidepressants and antipsychotics
    Medical condition: therapeutic use in clinical practise
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-005034-20 Sponsor Protocol Number: 228-13/06 Start Date*: 2007-03-08
    Sponsor Name:Klinik für Dermatologie und Venerologie, Universitätsklinikum Hamburg-Eppendorf
    Full Title: Doppelblinde, prospektiv-randomisierte, intraindividuell-halbseitenvergleichende Studie zur klinischen Wirksamkeit von Verrumal® Lsg. bei aktinischen Keratosen gegen Vehikel: Investigator-initiiert...
    Medical condition: Actinic keratosis is a precancerous skin growth usually caused by sun exposure. Symptoms: Rough and dry textured skin lesion, macule, patch, or growth on the skin Located on sun-exposed areas. Acti...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10000614 Actinic keratosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-004224-37 Sponsor Protocol Number: EREMIT Start Date*: Information not available in EudraCT
    Sponsor Name:Universität Leipzig
    Full Title: Everolimus in der Therapie von Patienten mit pulmonaler Hypertonie
    Medical condition: - steady or progressive pulmonary hypertension accompanied by at least two of the following parameters associated with a poor prognosis: - Cardiac index ≤ 2,1 l/min/m2 - 6 MWD ≤ 380 m - systolic RR...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10037400 Pulmonary hypertension PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-003420-33 Sponsor Protocol Number: NL78216 Start Date*: 2021-12-13
    Sponsor Name:Leiden University Medical Center
    Full Title: Tacrolimus versus mycophenolate for AutoImmune hepatitis patients with incompLete response On first line therapy: a Randomized trial (TAILOR study)
    Medical condition: Autoimmune hepatitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000580-24 Sponsor Protocol Number: Start Date*: 2019-05-17
    Sponsor Name:Hull & East Yorkshire Hospitals NHS trust
    Full Title: A single arm, open-label clinical trial of azithromycin in pulmonary sarcoidosis
    Medical condition: Sarcoidosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    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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