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Clinical trials for Vagal nerve stimulation

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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    20 result(s) found for: Vagal nerve stimulation. Displaying page 1 of 1.
    EudraCT Number: 2018-003464-32 Sponsor Protocol Number: VNS-MIR2018 Start Date*: 2019-11-05
    Sponsor Name:
    Full Title: Effect of mirtazapine on seizure frequency in medically refractory epileptic patients with vagal nerve stimulation
    Medical condition: epilepsy
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-004996-38 Sponsor Protocol Number: SP0969 Start Date*: 2013-11-25
    Sponsor Name:UCB BIOSCIENCES, Inc.
    Full Title: A MULTICENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS WITH EPILEPSY ≥4 YEARS TO <1...
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed) BE (Completed) IT (Completed) LV (Completed) EE (Completed) CZ (Completed) ES (Completed) PL (Completed) GB (Completed) LT (Completed) BG (Completed) RO (Completed) Outside EU/EEA SI (Completed) HR (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-001203-21 Sponsor Protocol Number: EP0083 Start Date*: 2022-11-18
    Sponsor Name:UCB Biopharma SRL
    Full Title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Subjects (>=16 to 80 Years of Age) With Partial S...
    Medical condition: Epilepsy (partial seizures with or without secondary generalization)
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-019361-28 Sponsor Protocol Number: N01358 Start Date*: 2011-03-15
    Sponsor Name:UCB BioSciences Inc. A Member of the UCB Group of Companies
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BRIVARACETAM IN SUBJECTS (≥16 TO 80 YEARS OLD) WITH PARTIAL ONSET SEIZURES
    Medical condition: Focal Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10061334 Partial seizures PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) CZ (Completed) ES (Completed) IT (Completed) GB (Completed) SE (Completed) FR (Ongoing) FI (Completed) AT (Completed) NL (Completed) EE (Completed) LT (Completed) LV (Completed) HU (Completed) BG (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2014-002321-35 Sponsor Protocol Number: E2007-G000-338 Start Date*: 2017-05-08
    Sponsor Name:Eisai Limited
    Full Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Cont...
    Medical condition: Seizures associated with Lennox-Gastaut Syndrome (LGS)
    Disease: Version SOC Term Classification Code Term Level
    19.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) BE (Prematurely Ended) LV (Prematurely Ended) PL (Prematurely Ended) CZ (Completed) FR (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002821-32 Sponsor Protocol Number: FENDEEP Start Date*: 2021-12-09
    Sponsor Name:Neurologia Aplicada, SLP
    Full Title: The FENDEEP Study: Fenfluramine for the treatment of different types of developmental and epileptic encephalopathies: a pilot trial exploring epileptic and non-epileptic outcomes.
    Medical condition: Five different types of developmental and epileptic encephalopathies (DEEs): SYNGAP1 and STXBP1 encephalopathies, inv-dup(15) encephalopathy, multifocal or bilateral Malformations of Cortical Devel...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10053551 Intractable epilepsy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-000474-38 Sponsor Protocol Number: ZX008-1504 Start Date*: 2016-09-13
    Sponsor Name:Zogenix International Limited
    Full Title: A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), ...
    Medical condition: Dravet's syndrome
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10073682 Dravet syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-003372-13 Sponsor Protocol Number: EP0100 Start Date*: 2023-11-17
    Sponsor Name:UCB Japan Co. Ltd.
    Full Title: An Open-Label, Single-Arm, Multicenter Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging from 1 Month to Less Than 4 Years of...
    Medical condition: Partial Seizures
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-006346-34 Sponsor Protocol Number: N01254 Start Date*: 2007-06-13
    Sponsor Name:UCB Pharma
    Full Title: An international, randomized, double-blind, parallel-group, placebo-controlled, flexible dose study: evaluation of the safety and efficacy of brivaracetam in subjects (>=16 to 70 years old) sufferi...
    Medical condition: Localization-related or generalized epilepsy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015037 Epilepsy LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) SE (Completed) DE (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-004714-27 Sponsor Protocol Number: N01258 Start Date*: 2011-10-05
    Sponsor Name:UCB Biosciences, Inc.
    Full Title: A Multicenter, Open-label, Four-arm, Randomized trial, Evaluating the Safety and Tolerability of Brivaracetam Intravenous Infusion and Bolus, Administered in BID Regimen as an Adjunctive Antiepilep...
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-001558-27 Sponsor Protocol Number: SP847 Start Date*: 2012-06-07
    Sponsor Name:UCB BIOSCIENCES, Inc
    Full Title: A MULTICENTER, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF LACOSAMIDE (LCM) ORAL SOLUTION (SYRUP) AS ADJUNCTIVE THERAPY IN CHILDREN WITH PARTIAL ONSET SEIZURES
    Medical condition: Epilepsy, partial onset seizures
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-006345-14 Sponsor Protocol Number: N01253 Start Date*: 2015-03-09
    Sponsor Name:UCB, Inc.
    Full Title: An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Se...
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2012-001446-18 Sponsor Protocol Number: SP0966 Start Date*: 2014-02-11
    Sponsor Name:UCB Biosciences Inc.
    Full Title: A MULTI-CENTER, OPEN-LABEL, EXPLORATORY STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS ≥1 MONTH TO <18 YEARS WITH EPILEPSY SYNDROMES ASSOCIATED WITH GE...
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) PL (Completed) Outside EU/EEA FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-002461-37 Sponsor Protocol Number: SP0980 Start Date*: 2012-04-05
    Sponsor Name:UCB BIOSCIENCES Inc
    Full Title: A PROSPECTIVE, MULTINATIONAL, OPEN-LABEL, SINGLE-ARM, EXPLORATIVE STUDY TO EVALUATE THE TOLERABILITY AND EFFICACY OF LACOSAMIDE WHEN ADDED TO LEVETIRACETAM WITH WITHDRAWAL OF THE CONCOMITANT SODIUM...
    Medical condition: Epilepsy with partial onset seizures
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) AT (Completed) ES (Completed) NL (Prematurely Ended) DK (Completed) BG (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2004-001856-35 Sponsor Protocol Number: N01114 Start Date*: 2005-04-04
    Sponsor Name:UCB S.A. Pharma Sector
    Full Title: A multicenter, double-blind, randomized, placebo-controlled, 4 parallel groups, dose-ranging trial evaluating the efficacy and safety of ucb 34714 used as adjunctive treatment at doses of 50, 150 a...
    Medical condition: Epilepsy - Refractory Partial Onset Seizure wheter or not secondarily generalized.
    Disease: Version SOC Term Classification Code Term Level
    7.1 10061334 LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FI (Completed) DE (Completed) CZ (Completed) GB (Completed) BE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-005177-23 Sponsor Protocol Number: N01395 Start Date*: 2012-09-27
    Sponsor Name:UCB Pharma SA
    Full Title: An Open-Label, Multicenter, Single-Arm Study to Evaluate the Reduction in Nonpsychotic Behavioral Side Effects in Subjects with Epilepsy Switching from Levetiracetam to Brivaracetam due to Nonpsych...
    Medical condition: Nonpyschotic Behavioural Side Effects in Subjects With Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002804-14 Sponsor Protocol Number: ZX008-1503 Start Date*: 2016-11-08
    Sponsor Name:Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc
    Full Title: An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome
    Medical condition: Seizures associated with Dravet syndrome
    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: GB (GB - no longer in EU/EEA) BE (Completed) DE (Completed) IT (Completed) DK (Completed) ES (Ongoing) FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-021448-17 Sponsor Protocol Number: CBGG492A2212 Start Date*: 2011-02-16
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, open-label, follow-up study to evaluate the long-term safety and tolerability of BGG492 TID as adjunctive therapy in patients with partial onset seizures completing double-blind, pla...
    Medical condition: Epilepsy Partial onset seizures
    Disease: Version SOC Term Classification Code Term Level
    12.1 10065336 Partial epilepsy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2021-003441-38 Sponsor Protocol Number: 1042-TSC-3001 Start Date*: Information not available in EudraCT
    Sponsor Name:Marinus Pharmaceuticals Inc.
    Full Title: A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy (TrustTSC)
    Medical condition: Tuberous Sclerosis Complex (TSC)-related epilepsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032062 Other forms of epilepsy, with intractable epilepsy LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) ES (Completed) IT (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001559-35 Sponsor Protocol Number: SP848 Start Date*: 2012-06-11
    Sponsor Name:UCB BIOSCIENCES, Inc
    Full Title: AN OPEN-LABEL STUDY TO DETERMINE SAFETY, TOLERABILITY, AND EFFICACY OF LONG-TERM ORAL LACOSAMIDE (LCM) AS ADJUNCTIVE THERAPY IN CHILDREN WITH EPILEPSY
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    19.1 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) HU (Completed) IT (Completed) Outside EU/EEA PL (Completed) FR (Completed)
    Trial results: View results
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    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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