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Clinical trials for Restless Legs Syndrome (RLS)

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44344   clinical trials with a EudraCT protocol, of which   7373   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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    40 result(s) found for: Restless Legs Syndrome (RLS). Displaying page 2 of 2.
    EudraCT Number: 2009-011107-23 Sponsor Protocol Number: OXN3502 Start Date*: Information not available in EudraCT
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A randomised, double-blind, placebo-controlled, parallel-group, multicenter study to demonstrate improvement of symptoms of RLS in subjects with moderate to severe idiopathic RLS with daytime sympt...
    Medical condition: Restless Legs Syndrome
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029205 - Nervous system disorders 10058920 Restless legs syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-011386-92 Sponsor Protocol Number: CHUBX 2008/35 Start Date*: 2009-08-07
    Sponsor Name:CHU de Bordeaux
    Full Title: Efficacité et tolérance de la toxine botulique dans le traitement du Syndrome des Jambes Sans Repos : étude non comparative sans insu de phase II selon un schéma "optimal en 2 étapes"
    Medical condition: Syndrôme des jambes sans repos (SJSR)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058920 Restless legs syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-001898-87 Sponsor Protocol Number: STRIVE Start Date*: 2019-09-26
    Sponsor Name:FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA
    Full Title: Pilot study on sleep pathologies treatments in patients with Vegetative or Minimally conscious state diagnosis for improving Consciounsess level. STRIVE Project.
    Medical condition: Patients diagnosed with vegetative state or minimally conscious state following brain damages without previous either psychiatric or neurological history and with evidence of (i) Obstructive Sleep ...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10058920 Restless legs syndrome PT
    21.1 10029205 - Nervous system disorders 10034715 Persistent vegetative state LLT
    20.0 100000004855 10078293 Obstructive sleep apnea hypopnea syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    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: 2018-001445-13 Sponsor Protocol Number: SP1006 Start Date*: 2023-09-18
    Sponsor Name:UCB Biopharma SRL
    Full Title: A Remote, Double-Blind, Randomized, Placebo-Controlled Study of Rotigotine Transdermal System in Adolescent Subjects With Idiopathic Restless Legs Syndrome
    Medical condition: Restless Legs Syndrome (RLS)
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    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: 2021-003403-18 Sponsor Protocol Number: RL0007 Start Date*: 2023-09-18
    Sponsor Name:UCB Biopharma SRL
    Full Title: A Remote, Open-Label, Long-Term, Follow-up Study to Determine the Safety, Tolerability, and Efficacy of Rotigotine Transdermal System as Monotherapy in Adolescents With Restless Legs Syndrome
    Medical condition: Restless Legs Syndrome (RLS)
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-001589-42 Sponsor Protocol Number: Tulir 02/01 Start Date*: 2004-12-25
    Sponsor Name:NeuroBiotec GmbH
    Full Title: Transdermal lisuride: Phase II/III study (efficacy and tolerance) of transdermal lisuride (patches) in patients with Restless Legs Syndrome (RLS)
    Medical condition: Patients suffering from Restless Legs Syndrome (RLS)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-000184-25 Sponsor Protocol Number: SK&F-101468/204 Start Date*: 2005-12-02
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared with Ropinirole Immediat...
    Medical condition: Restless Legs Syndrome (RLS)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) BE (Completed) AT (Completed) ES (Completed) GB (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    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: 2013-000574-30 Sponsor Protocol Number: VIT-RLS-2012-013 Start Date*: 2013-09-23
    Sponsor Name:Vifor (International) Inc.
    Full Title: A Randomised, Assessor- and Patient-blind, Multicentre, Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration of Ferric Carboxymaltose in Improving Outcomes in Iron ...
    Medical condition: Non-anaemic iron deficient patients with restless legs syndrome
    Disease: Version SOC Term Classification Code Term Level
    18.0 10027433 - Metabolism and nutrition disorders 10022970 Iron deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2005-005372-32 Sponsor Protocol Number: ROR104836 Start Date*: 2006-02-08
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound...
    Medical condition: Restless Legs Syndrome (RLS)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) ES (Completed) DE (Completed) DK (Completed) PT (Completed) CZ (Completed) HU (Completed) SK (Completed) IT (Completed)
    Trial results: View results
    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: 2019-004583-22 Sponsor Protocol Number: IDRLS Start Date*: 2021-06-13
    Sponsor Name:Medical University of Innsbruck
    Full Title: Prospective analysis of the therapeutic efficacy of iron isomaltoside in combination with or without dopaminergic therapy in patients with restless legs syndrome
    Medical condition: Restless leg syndorme
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned)
    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)
    EudraCT Number: 2011-003486-15 Sponsor Protocol Number: SP0934 Start Date*: 2012-06-13
    Sponsor Name:UCB BIOSCIENCES GmbH
    Full Title: A multi-center, randomized, double-blind, placebo-controlled, parallel group, polysomnography study to investigate safety and efficacy of the rotigotine transdermal patch in subjects with Restless ...
    Medical condition: Restless Legs Syndrome in patients with End Stage Renal Disease (ESRD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001529-28 Sponsor Protocol Number: P-Monofer-BD-02 Start Date*: 2012-06-13
    Sponsor Name:Pharmacosmos A/S
    Full Title: A Randomized, Prospective, Double-Blind, Comparative Placebo-Controlled Study of Intravenous Iron Isomaltoside 1000 (Monofer®) administered by Infusions to Iron-Deficient Blood Donors
    Medical condition: Female first-time bloddonors with iron deficiency
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004851 10022974 Iron deficiency anemia LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2009-010282-23 Sponsor Protocol Number: Bruxism-01 Start Date*: 2010-10-26
    Sponsor Name:Tandvården SU/Mölndal
    Full Title: A randomized, open-label, cross-over study to explore a potential involvement of a dopamine related dysfunction as a mechanism behind bruxism
    Medical condition: Patients with severe oral bruxism according to Polysomnographic cut-off criteria for bruxism: more than 4 bruxism episodes per hour, more than 6 bruxism bursts per episode and/or 25 bruxism bursts ...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10028037 Movement disorders (incl parkinsonism) HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-023471-26 Sponsor Protocol Number: P-Monofer-CKD-03 Start Date*: 2011-09-08
    Sponsor Name:Pharmacosmos A/S
    Full Title: A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison with...
    Medical condition: Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD5D)
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004857 10064848 Chronic kidney disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) DK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-023654-37 Sponsor Protocol Number: 34509 Start Date*: 2011-03-24
    Sponsor Name:Academic Medical Center
    Full Title: Effects of methylphenidate on the development of the dopaminergic system in the brain
    Medical condition: This project investigates whether the effects of methylfenidate on the outgrowth of the dopaminergic system are dependent on age. In a 16 week multicenter, dounle-blind, placebo controlled trial wi...
    Disease: Version SOC Term Classification Code Term Level
    15.0 10037175 - Psychiatric disorders 10064104 ADHD LLT
    15.0 10022891 - Investigations 10056941 MRI brain LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: NL (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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