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Clinical trials for Topiramate

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   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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    45 result(s) found for: Topiramate. Displaying page 2 of 3.
    EudraCT Number: 2012-003946-34 Sponsor Protocol Number: OB-401 Start Date*: 2013-10-30
    Sponsor Name:VIVUS, Inc.
    Full Title: A Qsymia™ CardiovascuLAr morbIdity and Mortality (AQCLAIM) Study in Subjects with Documented Cardiovascular Disease
    Medical condition: Cardiovascular Disease in overweight and obese subjects
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004849 10007648 Cardiovascular disease, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) CZ (Prematurely Ended) SK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-001017-16 Sponsor Protocol Number: FARM9A8J83 Start Date*: 2012-04-16
    Sponsor Name:IRCCS FONDAZIONE ISTITUTO NEUROLOGICO C. MONDINO
    Full Title: A randomized controlled trial of generic substitution of antiepileptic drugs
    Medical condition: Epilepsy or other diseases in which using: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, topiramate and valproate in mono or politerapy
    Disease: Version SOC Term Classification Code Term Level
    15.0 10037175 - Psychiatric disorders 10037175 Psychiatric disorders SOC
    15.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-017904-95 Sponsor Protocol Number: P09-005 Start Date*: 2010-06-28
    Sponsor Name:Upsher-Smith Laboratories, Inc.
    Full Title: Open-Label Extension Study to Evaluate the Safety of USL255 as Adjunctive Therapy in Patients with Refractory Partial-Onset Seizures who had Participated in P09-004, a Randomized, Multicenter, Doub...
    Medical condition: Refractory partial-onset seizures with or without secondary generalization
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10056209 Partial seizures with secondary generalisation PT
    14.0 10029205 - Nervous system disorders 10034090 Partial seizures, complex LLT
    14.0 10029205 - Nervous system disorders 10040703 Simple partial seizures PT
    14.0 10029205 - Nervous system disorders 10048674 Partial seizures with secondary generalization LLT
    14.0 10029205 - Nervous system disorders 10010145 Complex partial seizures PT
    14.0 10029205 - Nervous system disorders 10034091 Partial seizures, simple LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) ES (Completed) GR (Completed) HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003448-58 Sponsor Protocol Number: 3101-304-002 Start Date*: 2021-02-15
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Pa...
    Medical condition: Episodic migraine
    Disease: Version SOC Term Classification Code Term Level
    22.0 100000004852 10082019 Episodic migraine LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) DK (Completed) HU (Completed) NL (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-016996-31 Sponsor Protocol Number: P09-004 Start Date*: 2010-06-28
    Sponsor Name:Upsher-Smith Laboratories, Inc.
    Full Title: A Randomized, Multicenter, Double-Blind, Placebo–Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of USL255 as Adjunctive Therapy in Patients with Refractory Partial-O...
    Medical condition: Refractory partial-onset seizures with or without secondary generalization
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10056209 Partial seizures with secondary generalisation PT
    14.0 10029205 - Nervous system disorders 10034090 Partial seizures, complex LLT
    14.0 10029205 - Nervous system disorders 10040703 Simple partial seizures PT
    14.0 10029205 - Nervous system disorders 10048674 Partial seizures with secondary generalization LLT
    14.0 10029205 - Nervous system disorders 10010145 Complex partial seizures PT
    14.0 10029205 - Nervous system disorders 10034091 Partial seizures, simple LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) ES (Completed) GR (Completed) HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-003834-40 Sponsor Protocol Number: 07NR07 Start Date*: 2008-10-31
    Sponsor Name:UCL-INSTITUTE OF CHILD HEALTH
    Full Title: THE IMPACT OF REDUCING OVERTREATMENT ON QUALITY OF LIFE IN CHILDREN WITH REFRACTORY EPILEPSY
    Medical condition: We are studying a population of children with refractory epilepsy.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10053551 Intractable epilepsy LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-010584-16 Sponsor Protocol Number: 2009/001 Start Date*: 2010-10-25
    Sponsor Name:ZonMw
    Full Title: New pharmacotherapeutic treatment options for crack-cocaine dependent people in the Netherlands.
    Medical condition: Crack-cocaine dependence (according to DSM-IV)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001995 Amphetamine and other psychostimulant dependence LLT
    9.1 10001996 Amphetamine and other psychostimulant dependence, continuous use LLT
    9.1 10001997 Amphetamine and other psychostimulant dependence, episodic use LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002201-22 Sponsor Protocol Number: CAMG334ADE03 Start Date*: 2019-08-28
    Sponsor Name:Novartis Pharma GmbH
    Full Title: Assessment of Prolonged safety and tOLerability of erenumab in migraine patients in a Long-term OpeN-label study (APOLLON)
    Medical condition: Migraine prophylaxis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10027599 Migraine PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-003702-95 Sponsor Protocol Number: EPICURE SUB05T02 Start Date*: 2007-07-03
    Sponsor Name:ISTITUTO C. MONDINO
    Full Title: A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET'S SYNDROME (SMEI) NOT ADE...
    Medical condition: Dravet Syndrome
    Disease: Version SOC Term Classification Code Term Level
    10054859 PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-002198-30 Sponsor Protocol Number: EPICURESUB05T02 Start Date*: 2007-07-03
    Sponsor Name:Inserm-ISP Pole Recherches cliniques et thérapeutiques
    Full Title: A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AT THE MAXIMAL TOLERATED DOSAGE, AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH...
    Medical condition: Dravet Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10054859 Myoclonic epilepsy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-002211-18 Sponsor Protocol Number: CAMG334A2301 Start Date*: 2016-10-31
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 12-week double-blind, randomized, multicenter study comparing the efficacy and safety of once monthly subcutaneous 140 mg AMG 334 against placebo in adult episodic migraine patients who have fail...
    Medical condition: Migraine Prevention
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10027599 Migraine PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) SE (Completed) DE (Completed) FI (Completed) ES (Completed) AT (Completed) DK (Completed) BE (Completed) GR (Completed) NL (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000600-42 Sponsor Protocol Number: I5Q-MC-CGAW Start Date*: 2018-06-26
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults with Treatment-Resistant Migraine - The CONQUER Study
    Medical condition: Treatment-resistant Migraine
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10027602 Migraine headache LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) ES (Completed) CZ (Completed) BE (Completed) NL (Completed) HU (Completed) DK (Prematurely Ended) GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-000781-10 Sponsor Protocol Number: STANDLOW Start Date*: 2018-05-31
    Sponsor Name:IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    Full Title: EFFICACY AND TOLERABILITY OF LOW VS. STANDARD DAILY DOSES OF ANTIEPILEPTIC DRUGS IN NEWLY DIAGNOSED, PREVIOUSLY UNTREATED EPILEPSY (STANDLOW). A MULTICENTER, RANDOMIZED, SINGLE-BLIND, PARALLEL GROU...
    Medical condition: EPILEPSY
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10015046 Epilepsy, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-005065-64 Sponsor Protocol Number: CBGG492A2202 Start Date*: 2009-03-12
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, double-blind, randomized, placebo-controlled, two-arm parallel-group study of BGG492 as monotherapy in individuals with refractory partial seizures undergoing inpatient evaluation fo...
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061334 Partial seizures LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-004827-30 Sponsor Protocol Number: RASLOW Start Date*: 2017-03-21
    Sponsor Name:AZIENDA OSPEDALIERA "BIANCHI-MELACRINO-MORELLI"
    Full Title: RAPID VERSUS SLOW WITHDRAWAL OF ANTIEPILEPTIC MONOTHERAPY IN TWO-YEAR SEIZURE-FREE ADULTS PATIENTS WITH EPILEPSY (RASLOW) STUDY: A PRAGMATIC MULTICENTRE, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY.
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10015046 Epilepsy, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003392-34 Sponsor Protocol Number: FAST-trail Start Date*: 2021-10-19
    Sponsor Name:Odense Universitetshospital
    Full Title: “FAST ACUTE SEDATION AT INTENSIVE CARE VS. HIGH-DOSE I.V. ANTI-SEIZURE MEDICATION FOR TREATMENT OF NON-CONVULSIVE STATUS EPILEPTICUS - A RANDOMIZED, MULTICENTER TRIAL (FAST TRIAL)”
    Medical condition: Verfied non convulsive status epilepticus refractory to standard treatment with benzodiazepines and at least one first line drug
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10041962 Status epilepticus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003172-43 Sponsor Protocol Number: TV48125-CNS-30058 Start Date*: 2017-05-31
    Sponsor Name:Teva Branded Pharmaceutical Products R&D, Inc.
    Full Title: A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety of TEV-48125 for the Prevention of Cluster Headache
    Medical condition: Cluster headache (CH)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) GB (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended) NL (Completed) PL (Prematurely Ended) FI (Completed)
    Trial results: View results
    EudraCT Number: 2015-004598-34 Sponsor Protocol Number: TV48125-CNS-30050 Start Date*: 2016-11-24
    Sponsor Name:Teva Branded Pharmaceutical Products R&D, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for...
    Medical condition: Episodic Migraine
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004852 10027602 Migraine headache LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) ES (Completed) FI (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-002069-19 Sponsor Protocol Number: 333369-EPY-2003 Start Date*: 2005-04-19
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects with Refractory Partial Seizures
    Medical condition: Refractory partial epilepsy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-000763-23 Sponsor Protocol Number: ANJ900D3501 Start Date*: 2021-12-28
    Sponsor Name:Anji Pharma (US) LLC
    Full Title: A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo- and Comparator-Controlled Study to Compare the Glycemic Effects, Safety, and Tolerability of Metformin Hydrochloride Delayed-Releas...
    Medical condition: Type 2 Diabetes Mellitus with varying renal function from normal up to CKD3B
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) PL (Completed) BG (Completed) HU (Completed)
    Trial results: (No results available)
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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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