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Clinical trials for Tesofensine

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    8 result(s) found for: Tesofensine. Displaying page 1 of 1.
    EudraCT Number: 2016-003694-18 Sponsor Protocol Number: TM002 Start Date*: 2017-01-18
    Sponsor Name:Saniona A/S
    Full Title: A double-blind, randomized, placebo-controlled, multiple-dose, multi-centre safety and efficacy study of co-administration of tesofensine/metoprolol in subjects with Prader-Willi syndrome (PWS) "Se...
    Medical condition: Prader Willi syndrome (PWS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10036476 Prader-Willi syndrome PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2006-002862-20 Sponsor Protocol Number: NS2330-001 Start Date*: 2006-08-03
    Sponsor Name:NeuroSearch A/S
    Full Title: Effect of tesofensine on weight reduction in patients with obesity. A randomised, double-blind, placebo-controlled, parallel-group, multi-centre study.
    Medical condition: Obesity
    Disease: Version SOC Term Classification Code Term Level
    8.1 10029883 Obesity LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-001121-10 Sponsor Protocol Number: NS2330-004 Start Date*: 2007-05-10
    Sponsor Name:NeuroSearch A/S
    Full Title: Evaluation of long term safety of tesofensine in patients with obesety.
    Medical condition: Obesity
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029883 Obesity LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-005522-19 Sponsor Protocol Number: TM001 Start Date*: 2016-03-30
    Sponsor Name:Saniona, A/S
    Full Title: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTIPLE-DOSE, TWO-CENTRE, SAFETY AND EFFICACY STUDY OF CO-ADMINISTRATION OF TESOFENSINE/METOPROLOL TREATMENT IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
    Medical condition: Diabetes mellitus type 2
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-003672-12 Sponsor Protocol Number: TM005 Start Date*: 2019-01-29
    Sponsor Name:Saniona A/S
    Full Title: A 24-week phase 2, double-blind, randomized, placebo-controlled, single-centre safety and efficacy study to evaluate overall safety and tolerability of co-administration of tesofensine and metoprol...
    Medical condition: Hypothalmic injury-induced obesity (HIO)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004860 10013367 Disorders of the pituitary gland and its hypothalamic control LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-000146-18 Sponsor Protocol Number: TM008 Start Date*: 2022-02-09
    Sponsor Name:Saniona A/S
    Full Title: A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose finding, Multi-center, 36-week Safety and Efficacy Study with Open-label Extension Period of Tesomet in Subjects with Hypothalamic Obe...
    Medical condition: Hypothalamic Obesity
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004860 10013367 Disorders of the pituitary gland and its hypothalamic control LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-000127-12 Sponsor Protocol Number: TM006 Start Date*: 2022-01-03
    Sponsor Name:Saniona A/S
    Full Title: A Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi center, 16-week Dose finding, Safety and Efficacy Study with Open-label Extension Period of Tesomet in Adult and Adolescent Subjects ...
    Medical condition: Prader-Willi Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10036476 Prader-Willi syndrome PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2004-001100-12 Sponsor Protocol Number: 1198.022 Start Date*: 2004-08-09
    Sponsor Name:Boehringer Ingelheim Pharma Ges mbH
    Full Title: A multi-centre, double-blind, parallel-group, randomised, placebo-controlled study to investigate the safety and tolerability of 0.25, 0.5 and 1.0 mg NS 2330 orally and once daily during a 14-week ...
    Medical condition: Mild to moderate dementia of the Alzheimer's type
    Disease: Version SOC Term Classification Code Term Level
    5 10001897 High
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) SK (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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