Flag of the European Union EU Clinical Trials Register Help

Clinical trials for restless legs syndrome

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   44381   clinical trials with a EudraCT protocol, of which   7393   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
    Select Country:
    		 Select Age Range:
    Select Trial Status:
    		 Select Trial Phase:
    Select Gender:
    Select Date Range:
    to
    Select Rare Disease:
    IMP with orphan designation in the indication
    Orphan Designation Number:
    Results Status:
    Clear advanced search filters
     
    5 result(s) found for: restless legs syndrome. Displaying page 1 of 1.
    EudraCT Number: 2007-002074-58 Sponsor Protocol Number: IIS-2007-01 Start Date*: 2007-11-29
    Sponsor Name:Instituto de Investigaciones del Sueño
    Full Title: Estudio unicéntrico, aleatorizado, doble ciego, de diseño cruzado, controlado con placebo, de nueve semanas de duracion para evaluar la eficacia de oxibato sodico en pacientes con el síndrome de la...
    Medical condition: El Síndrome de las piernas inquietas idiopático (SPI)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058920 Restless legs syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-002130-35 Sponsor Protocol Number: GARBO-2005-02 Start Date*: 2005-09-15
    Sponsor Name:INSTITUTO DE ESTUDIOS DEL SISTEMA NERVIOSO
    Full Title: A Multicenter, Randomized, Parallel groups, Double-Blind, Placebo-controlled and 12 weeks follow-up Study to Evaluate the Safety, Tolerability and Efficacy of Pregabalin in Idiopathic Restless Legs...
    Medical condition: Idiopathic Restless legs Syndrome
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-001516-41 Sponsor Protocol Number: FAB-LEV-2005-01 Start Date*: 2005-09-07
    Sponsor Name:Clínica Plató Fundació Privada
    Full Title: Efficacy and safety of Levetiracetam treatment in patients suffering from Restless Legs Syndrome Eficacia y seguridad de un tratamiento con levetiracetam en pacientes con síndrome idiopático de pie...
    Medical condition: Restless legs syndrome (RLS)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004580-12 Sponsor Protocol Number: IISS-57325 Start Date*: 2018-03-02
    Sponsor Name:Instituto de investigación del sueño
    Full Title: Treatment of Restless Legs Syndrome with the Hypocretin Antagonist Suvorexant
    Medical condition: Treatment of Restless Legs Syndrome with the Hypocretin Antagonist Suvorexant
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-004825-29 Sponsor Protocol Number: IIS-2011-01 Start Date*: 2011-11-30
    Sponsor Name:Instituto de Investigaciones del Sueño
    Full Title: TREATMENT WITH ROTIGOTINE OF RLS PATIENTS WITH AN INSUFFICIENT RESPONSE TO DOPAMINE AGONIST WITH INTERMEDIATE HALF-LIFE.
    Medical condition: Restless Legs Syndrom
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon Feb 16 09:20:11 CET 2026 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA