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Clinical trials for Lamictal

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   44336   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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    14 result(s) found for: Lamictal. Displaying page 1 of 1.
    EudraCT Number: 2015-004901-18 Sponsor Protocol Number: LAM107844 Start Date*: 2016-08-03
    Sponsor Name:GlaxoSmithKline Research & Development
    Full Title: Clinical Evaluation of lamotrigine in Epilepsy
    Medical condition: Epilepsy
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004872-31 Sponsor Protocol Number: SCA102833 Start Date*: 2016-12-21
    Sponsor Name:GlaxoSmithKline
    Full Title: The Evaluation of Lamictal as an Add-on Treatment for Bipolar I Disorder in Children and Adolescents, 10 to 17 Years of Age
    Medical condition: Bipolar Disorder
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004873 10004938 Bipolar disorders HLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004954-13 Sponsor Protocol Number: E2090-AS886-202 Start Date*: 2017-04-24
    Sponsor Name:Eisai Taiwan Inc.
    Full Title: A Multi-center, Randomized, Open-label, Parallel-group, Dose-titration, Add-on, Comparative Study in Evaluating the Efficacy and Safety of Zonisamide (Zonegran) and Lamotrigine (Lamictal) for Subje...
    Medical condition: Epilepsy
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2005-004023-19 Sponsor Protocol Number: A0081046 Start Date*: 2006-05-25
    Sponsor Name:Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United Kingdom
    Full Title: A RANDOMIZED, COMPARATIVE, DOUBLE-BLIND, PARALLEL-GROUP, MULTICENTER, MONOTHERAPY, STUDY OF PREGABALIN (LYRICA) AND LAMOTRIGINE (LAMICTAL) IN PATIENTS WITH NEWLY DIAGNOSED PARTIAL SEIZURES
    Medical condition: Epilepsy; Patients with newly diagnosed partial seizures (with or without secondary generalization)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061334 Partial seizures LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) PT (Completed) ES (Completed) BE (Completed) IE (Completed) CZ (Completed) LT (Completed) DE (Completed) SK (Completed) IT (Completed) HU (Completed) FI (Completed) EE (Completed) BG (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2017-001514-29 Sponsor Protocol Number: LAM115377 Start Date*: 2017-08-11
    Sponsor Name:GlaxoSmithKline KK
    Full Title: A multi-center, uncontrolled, open-label, evaluation of Lamotrigine monotherapy on newly diagnosed typical absence seizures in children and adolescents
    Medical condition: Typical absence seizure
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000014665 10000331 Absence seizure LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-004343-21 Sponsor Protocol Number: LAM100036 Start Date*: Information not available in EudraCT
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures
    Medical condition: Epilepsy - Primary genralised tonic clonic seizures
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-001606-66 Sponsor Protocol Number: OLZvsLMT-DB Start Date*: 2005-06-16
    Sponsor Name:AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
    Full Title: OLANZAPINE VS LAMOTRIGINE ADD-ON TO LITHIUM:EFFICACY ON ANXIETY SYMPTOMS IN REMITTING BIPOLAR PATIENTS
    Medical condition: EFFICACY ON ANXIETY SYMPTOMS IN REMITTING BIPOLAR PATIENTS
    Disease: Version SOC Term Classification Code Term Level
    6.1 10057667 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-004342-41 Sponsor Protocol Number: LAM100034 Start Date*: 2005-04-28
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects with Partial Seizures
    Medical condition: Epilepsy -partial seizures
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-001515-36 Sponsor Protocol Number: 200776 Start Date*: 2017-08-11
    Sponsor Name:GlaxoSmithKline K.K.
    Full Title: Valproate dose reduction and its clinical evaluation by introducing lamotrigine in Japanese women with epilepsy – single arm, multicenter, and open-label study
    Medical condition: Partial seizures (including secondary generalized seizures) or tonic-clonic seizures with or without myoclonus but without other generalized seizure type(s)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000038485 10043999 Tonic-clonic epilepsy LLT
    20.0 100000014703 10065336 Partial epilepsy LLT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-004513-33 Sponsor Protocol Number: OCTUMI-02 Start Date*: 2008-05-08
    Sponsor Name:University of Oxford
    Full Title: Comparative Evaluation of QUEtiapine-Lamotrigine combination versus quetiapine monotherapy (and folic acid versus placebo) in patients with bipolar depression
    Medical condition: Bipolar depression
    Disease: Version SOC Term Classification Code Term Level
    13.1 10037175 - Psychiatric disorders 10004936 Bipolar depression LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-005405-21 Sponsor Protocol Number: UMCN-AKF 07.06 Start Date*: 2008-01-21
    Sponsor Name:Radboud University Nijmegen Medical Centre
    Full Title: The influence of Raltegravir (MK_0518) on the pharmacokinetics of single-dose Lamotrigine in healthy male subjects (GRANOLA)
    Medical condition: HIV infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adults Gender: Male
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-004878-15 Sponsor Protocol Number: LAM115376 Start Date*: 2016-12-21
    Sponsor Name:GlaxoSmithKline K.K. (GSK)
    Full Title: A multi-center, uncontrolled, open-label, evaluation of lamotrigine monotherapy in adult subjects with newly diagnosed epilepsy or recurrent epilepsy (currently untreated).
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-001884-64 Sponsor Protocol Number: UoL000314(UoL) Start Date*: 2012-06-07
    Sponsor Name:University of Liverpool [...]
    1. University of Liverpool
    2. The Walton Centre NHS Foundation Trust
    Full Title: A pragmatic randomised controlled trial comparing the effectiveness and cost effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of Standard And New ...
    Medical condition: Epilepsy
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-023505-36 Sponsor Protocol Number: E2080-G000-303 Start Date*: Information not available in EudraCT
    Sponsor Name:Eisai Ltd
    Full Title: A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to ...
    Medical condition: Lennox Gastaut Syndrome
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) IT (Completed) GR (Completed) Outside EU/EEA
    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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