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Clinical trials for Status epilepticus

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 ).  
     
    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.
    Study title: Qureshi A, Wassmer E, Davies P, Berry K, Whitehouse WP. Comparative audit of intravenous lorazepam and diazepam in the emergency treatment of convulsive status epilepticus in children. Seizure. 2002 Apr;11(3):141-4.Qureshi A, Wassmer E, Davies P, Berry K, Whitehouse WP. Comparative audit of intravenous lorazepam and diazepam in the emergency treatment of convulsive status epilepticus in children. Seizure. 2002 Apr;11(3):141-4.
    Active substance: DIAZEPAM
    Study summary document link (including results):
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    Document reference: 25945
    Study title: A 13C –urea breath test in children with Helicobacter pylori infection: assessment of eradication therapy and follow-up treatmentStatus Epilepticus in children. Experience with intravenous valproate. Update of treatment guidelines - Campistol and al. - 1999 ( Rev. Neurol.1999 - 29 : 359-65 ) Publication 1 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006
    Active substance: UREA
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    Document reference: 39144
    Study title: A rapid lateral flow stool antigen immunoassay and 14C-urea breath test for the diagnosis and eradication of Helicobacter pylori infection in childrenSodium Vallproate in status epilepticus - S. JHA 2003 (Neurol. India - 2003 - 51:421-2) Publication in Epilim-Reports of clinical studies Vol II - E. TRINKA - 06/11/2006
    Active substance: UREA
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    Document reference: 39141
    Study title: No radiation protection reasons for restrictions on 14C urea breath tests in childrenSodium Vallproate in status epilepticus - S. JHA 2003 (Neurol. India - 2003 - 51:421-2) Publication in Epilim-Reports of clinical studies Vol II - E. TRINKA - 06/11/2006
    Active substance: UREA
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    Document reference: 39142
    Study title: OPEN-LABEL, RATE-ESCALATION, MULTICENTER STUDY TO ASSESS SAFETY, TOLERANCE AND PHARMACOKINETICS OF INTRAVENOUSLY ADMINISTERED FOSPHENYTOIN SODIUM IN THE ACUTE TREATMENT OG GENERALIZED CONVULSIVE STATUS EPILEPTICUS.
    Active substance: FOSPHENYTOIN
    Study summary document link (including results): PhRMA Web Synopsis.pdf
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    Document reference: 28608
    Study title: Aydin OF, Senbil N, Gurer YK. J Child Neurol. 2006 Mar;21(3):256-60. Nonconvulsive status epilepticus on electroencephalography in a case with subacute sclerosing PanencephalitisAydin OF, Senbil N, Gurer YK. J Child Neurol. 2006 Mar;21(3):256-60. Nonconvulsive status epilepticus on electroencephalography in a case with subacute sclerosing Panencephalitis
    Active substance: INOSINE
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    Document reference: 30073
    Study title: Mehta V, Singhi P, Singhi S. Intravenous sodium valproate versus diazepam infusion for the control of refractory status epilepticus in children: a randomized controlled trial. J Child Neurol. 2007 Oct;22(10):1191-7.Mehta V, Singhi P, Singhi S. Intravenous sodium valproate versus diazepam infusion for the control of refractory status epilepticus in children: a randomized controlled trial. J Child Neurol. 2007 Oct;22(10):1191-7.
    Active substance: DIAZEPAM
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    Document reference: 25938
    Study title: 99mTc-HMPAO single photon emission computed tomography (SPECT) in both asphyxiated and epileptic children with or without status epilepticusJ Child Neurol. 2005 Jul; 20(7):560-5. Oner n 2005
    Active substance: CERETEC
    Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc
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    Document reference: 48618
    Study title: Albani M. An effective dose schedule for phentoin treatment of status epilepticus in infancy and childhood. Neuropädiatrie 1977; 8: 286-292Albani M. An effective dose schedule for phentoin treatment of status epilepticus in infancy and childhood. Neuropädiatrie 1977; 8: 286-292
    Active substance: PHENYTOIN
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    Document reference: 33969
    Study title: Hussain et al Aetiology, course and outcome of children admitted to paediatric intensive care with convulsive status epilepticus: a retrospective 5-year review. Seizure 2007, Jun; 16(4):305-12Hussain et al Aetiology, course and outcome of children admitted to paediatric intensive care with convulsive status epilepticus: a retrospective 5-year review. Seizure 2007, Jun; 16(4):305-12
    Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE
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    Document reference: 33955
    Study title: Hayashi, K., et al., Efficacy of intravenous midazolam for status epilepticus in childhood. Pediatr Neurol, 2007. 36(6): p. 366-72. 4. Hayashi, K., et al., Efficacy of intravenous midazolam for status epilepticus in childhood. Pediatr Neurol, 2007. 36(6): p. 366-72. 4.
    Active substance: MIDAZOLAM
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    Document reference: 32003
    Study title: Intravenous valproic acid administration in status epilepticus - Czapinski P. and al. - 1998 ( Neurol. Neurochir. Pol. 1998 ; 32 : 11-22 ) Publication 3 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006
    Active substance: VALPROIC ACID
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    Document reference: 45491
    Study title: Status Epilepticus in children. Experience with intravenous valproate. Update of treatment guidelines - Campistol and al. - 1999 ( Rev. Neurol.1999 - 29 : 359-65 ) Publication 1 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006
    Active substance: VALPROIC ACID
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    Document reference: 45513
    Study title: Use of injectable valproic acid in status epilepticus - Giroud M. and al. - 1993 ( Drug Invest 1993 ; 5 : 154-9 ) Publication 2 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006
    Active substance: VALPROIC ACID
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    Document reference: 45525
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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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