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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   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.
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    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.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
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    Study title: Phase 1, Multicenter open-label trial to gain additional experience with topiramate among subjects with infantile spasms
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44912
    Study title: 41. Phase 3, double-blind, parallel-group, safety and efficacy study of TPM monotherapy in adults with refractory partial epilepsy.
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44975
    Study title: Prospective study of first-choice topiramate therapy in newly diagnosed infantile spasms.
    Active substance: NITRAZEPAM
    Study summary document link (including results):
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    Document reference: 32653
    Study title: 38. TOPAMAX in der Behandlung des WEST Syndrom (TOPAMAX in the treatment of West Syndrom (patients < 2 years)).
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44972
    Study title: 38. Topamax in der Therapie kindlicher Epilepsien (Topamax in the Therapy of Childlike Epilepsy)
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44881
    Study title: 39. TOPAMAX in Patienten mit fokalen und generalisierten tonisch klonischen Anfällen (TOPAMAX in Patients with Focally and Generalised Tonic Clonic Seizures) TOP-GER-3 (patients > 12)
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44882
    Study title: 4. A pilot study of topiramate in childhood absence epilepsy.
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44938
    Study title: 37. Topamax 1st line add on (patients >12 years)
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44902
    Study title: 37. TOPAMAX in Patienten mit fokalen und generalisierten tonisch klonischen Anfällen (TOPAMAX in Patients with Focally and Generalised Tonic Clonic Seizures (patients > 12 years)).
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44971
    Study title: 4. Phase 3, randomized, double-blind, PBO-controlled, parallel group, multicenter, dose-response study to evaluate the efficacy and safety of TPM vs. PBO in migraine prophylaxis (plus OL Ext)
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44837
    Study title: 40. Phase 3, open-label, safety and efficacy, adjunctive or monotherapy study in adults with refractory partial epilepsy originally entered in Studies Y1/Y2/Y3, and who received PBO in the original study.
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44974
    Study title: 41. TOPAMAX in der Behandlung des WEST Syndrom (TOPAMAX in the treatment of West Syndrom) (patients < 2 years)
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44903
    Study title: 5. Phase 3, randomized, double-blind, parallel group, multicenter, PBO- and active-controlled, dose-response study to evaluate the efficacy and safety of 2 doses of TPM vs. PBO and PROP in migraine prophylaxis (plus blinded Ext)
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44838
    Study title: 39. Open-label, safety and efficacy, adjunctive or monotherapy study in asubjects ? 14 years of age with any seizure type.
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44973
    Study title: 5. Topiramate clinical trial in primary generalized tonic-clonic seizures (long-term extension).
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44939
    Study title: 6. Open study of topamax as adjunct treatment in patients with partial onset seizures : assessing the low and slow titration regimen.
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44940
    Study title: 6. Phase 3, randomized, double-blind, parallel group, multicenter, PBO- and active-controlled, dose-response study to evaluate the efficacy and safety of 2 doses of TPM vs. PBO and PROP in migraine prophylaxis (plus blinded Ext)
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44839
    Study title: 7. Open naturalistic individual dose optimisation trial assessing tolerability and efficacy of topiramate
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44874
    Study title: 7. Open naturalistic individual dose optimisation trial assessing tolerability and efficacy of topiramate.
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44941
    Study title: 7. Single centre topiramate monotherapy trial
    Active substance: TOPIRAMATE
    Study summary document link (including results):
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    Document reference: 44840
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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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