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Clinical trials for Tasimelteon

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 ).  
     
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    7 result(s) found for: Tasimelteon. Displaying page 1 of 1.
    EudraCT Number: 2010-020912-12 Sponsor Protocol Number: VP-VEC-162-3202 Start Date*: 2010-08-26
    Sponsor Name:Vanda Pharmaceuticals Inc.
    Full Title: Open-label safety study of a 1-year 20 mg dose regimen of tasimelteon for the treatment of Non-24-Hour Sleep-Wake Disorder (N24HSWD) in blind individuals with no light perception.
    Medical condition: Non-24 Hour Sleep-Wake Disorder
    Disease: Version SOC Term Classification Code Term Level
    12.1 10013419 Disruptions of 24 hour sleep-wake cycle LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-005475-40 Sponsor Protocol Number: VP-VEC-162-3502 Start Date*: 2022-06-08
    Sponsor Name:Vanda Pharmaceuticals Inc.
    Full Title: A multicenter, double-blind, randomized study to evaluate the effects of tasimelteon vs. placebo in participants with Delayed Sleep-Wake Phase Disorder (DSWPD)
    Medical condition: Delayed Sleep-Wake Phase Disorder (DSWPD)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029205 - Nervous system disorders 10041013 Sleep-wake schedule disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003394-15 Sponsor Protocol Number: VP-VEC-162-4201 Start Date*: 2016-06-28
    Sponsor Name:Vanda Pharmaceuitcals Inc.
    Full Title: OPEN-LABEL STUDY TO INVESTIGATE THE PHARMACOKINETICS AND SAFETY OF TASIMELTEON IN TOTALLY BLIND CHILDREN AND ADOLESCENTS WITH NON-24-HOUR SLEEP- WAKE DISORDER
    Medical condition: This study will be an open-label, single dose, non-controlled trial to evaluate the pharmacokinetics and safety of tasimelteon in children who are 3 years to less than 18 years of age, totally blin...
    Disease: Version SOC Term Classification Code Term Level
    19.0 10037175 - Psychiatric disorders 10040984 Sleep disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003198-14 Sponsor Protocol Number: VP-VEC-162-3106 Start Date*: 2015-12-21
    Sponsor Name:Vanda Pharmaceuticals Inc
    Full Title: A multicenter, randomized, double-blind, placebo-controlled, parallel study to investigate the efficacy and safety of multiple oral doses of tasimelteon and matching placebo in travelers with Jet L...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.1 10037175 - Psychiatric disorders 10040984 Sleep disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-004520-35 Sponsor Protocol Number: VP-VEC-162-3204 Start Date*: 2012-12-06
    Sponsor Name:Vanda Pharmaceuticals Inc.
    Full Title: AN EXTENSION OPEN-LABEL SAFETY STUDY OF A 24-MONTH 20MG DOSE REGIMEN OF TASIMELTEON FOR THE TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER (N24HSWD) IN BLIND INDIVIDUALS WITH NO LIGHT PERCEPTION WHO ...
    Medical condition: Blind males or females with no conscious light perception and the complaint of a sleep-wake disorder associated with Non-24 Hour Sleep- Wake Disorder
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029205 - Nervous system disorders 10009191 Circadian rhythm sleep disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-002213-21 Sponsor Protocol Number: VP-VEC-162-2102 Start Date*: 2016-08-15
    Sponsor Name:Vanda Pharmaceuticals Inc
    Full Title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL PROOF OF CONCEPT STUDY TO EVALUATE THE EFFECTS OF MULTIPLE ORAL DOSES OF TASIMELTEON AND MATCHING PLACEBO IN TRAVELERS WITH JET...
    Medical condition: Jet Lag Disorder (JLD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10040984 Sleep disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-000281-35 Sponsor Protocol Number: VP-VEC-162-3201 Start Date*: 2011-06-09
    Sponsor Name:Vanda Pharmaceuticals Inc.
    Full Title: A Multicenter, Randomized, Double-Mask, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of 20 mg Tasimelteon versus Placebo in Totally Blind Subjects with N24HSWD followed...
    Medical condition: Blind males or females with no conscious light perception and the complaint of a sleep-wake disorder associated with Non-24 Hour Sleep-Wake Disorder.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10009191 Circadian rhythm sleep disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
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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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