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Clinical trials for Atkins diet

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   44341   clinical trials with a EudraCT protocol, of which   7370   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: Atkins diet. Displaying page 1 of 1.
    EudraCT Number: 2021-002481-40 Sponsor Protocol Number: TAK-935-3002 Start Date*: 2021-07-22
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subj...
    Medical condition: Lennox-Gastaut Syndrome (LGS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA IT (Completed) FR (Completed) ES (Completed) LV (Completed) GR (Completed) NL (Completed) BE (Completed) PL (Completed) HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-002480-22 Sponsor Protocol Number: TAK-935-3001 Start Date*: 2021-07-22
    Sponsor Name:Takeda Development Center Americas, Inc
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Young Adul...
    Medical condition: Dravet Syndrome (DS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10073682 Dravet syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA IT (Completed) FR (Completed) ES (Completed) LV (Completed) GR (Completed) NL (Completed) BE (Completed) PL (Completed) HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-002482-17 Sponsor Protocol Number: TAK-935-3003 Start Date*: 2022-05-09
    Sponsor Name:Takeda Development Center Americas, Inc
    Full Title: A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or ...
    Medical condition: Dravet Syndrome (DS) Lennox-Gastaut Syndrome (LGS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10073682 Dravet syndrome LLT
    20.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) ES (Trial now transitioned) NL (Trial now transitioned) HU (Trial now transitioned) FR (Trial now transitioned) GR (Trial now transitioned) IT (Trial now transitioned) LV (Trial now transitioned) PL (Trial now transitioned) Outside EU/EEA DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-004496-12 Sponsor Protocol Number: 1042-PCDH19-3002 Start Date*: 2019-09-26
    Sponsor Name:Marinus Pharmaceuticals, Inc.
    Full Title: A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female children with protocadherin 19 (PCDH19)-related epilepsy followed by long-term open-label treatment
    Medical condition: protocadherin 19 (PCDH19)-related epilepsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032061 Other forms of epilepsy LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Female
    Trial protocol: FR (Completed) NL (Prematurely Ended) PL (Completed) HU (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-001180-23 Sponsor Protocol Number: 1042-CDD-3001 Start Date*: 2018-12-06
    Sponsor Name:Marinus Pharmaceuticals, Inc.
    Full Title: A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Children and Young Adults with Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) Followed b...
    Medical condition: Treatment of seizures in children and young adults with genetically confirmed cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032062 Other forms of epilepsy, with intractable epilepsy LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Completed) FR (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002485-39 Sponsor Protocol Number: TAK-935-18-001(OV935)Amendment1 Start Date*: 2019-06-14
    Sponsor Name:Ovid Therapeutics, Inc.
    Full Title: A PHASE 2, PROSPECTIVE, INTERVENTIONAL, OPEN-LABEL, MULTI-SITE, EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF TAK-935 (OV935) AS ADJUNCTIVE THERAPY IN PATIENTS WITH RARE EPILEP...
    Medical condition: developmental and epileptic encephalopathies
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) PL (Trial now transitioned) PT (Trial now transitioned) Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2021-000138-33 Sponsor Protocol Number: R4461-PLD-20100 Start Date*: 2021-12-21
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A Randomized Double-Blind Placebo-Controlled Study of the LEPR Agonist Antibody REGN4461 for the Treatment of Metabolic Abnormalities in Patients with Familial Partial Lipodystrophy
    Medical condition: Familial Partial Lipodystrophy
    Disease: Version SOC Term Classification Code Term Level
    21.1 10040785 - Skin and subcutaneous tissue disorders 10053857 Partial lipodystrophy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) FR (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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