A definite syndromic diagnosis, according to the ILAE Classification criteria, ( ) and epilepsies and epileptic syndromes () in epileptic children in a . de la Clasificación Internacional de las Epilepsias y Síndromes Epilépticos en los . Early • In , the ILAE was founded. • In the s, a classification system was purposed by Herni. Gastaut. s. • Anatomy based classification. DOCUMENTOS. CLASIFICACIÓN Y TÉRMINOS EN EPILEPSIA. ILAE Report of the ILAE Classification Core Group. Epilepsia. ILAE Proposal for.
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Clinical Trials Register
Clear advanced search filters. For these items you should use the filters and not add them to your search terms in the text field. EU Clinical Trials Register. Plans for treatment or care after the subject has ended the participation in the trial if it is different from the expected normal treatment of that condition.
The IMP has been designated in this indication as an orphan drug in the Community. Symptomatic generalized epilepsy, e. Lifetime history of suicide attempt, or suicidal ideation in past 6 months? Time to the second primary generalized tonic clonic PGTC seizure.
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History of partial onset seizures or EEG findings indicating partial onset seizures? Subjects who choose not to continue in open label study must complete an up to 4-week blinded taper followed by a day Safety Follow-up Period. IMP with orphan designation in the indication.
Dlasificacion can enter open label study after the completion of Visit 10 Week 24 or End of Treatment Visit and a 4-week blinded transition. A study to assess the safety and efficacy of Lacosamide versus placebo a pill without active medication in patients with idiopathic generalised epilepsy who are already taking anti-epileptic medications. Subject is on a ketogenic diet. Antecedentes de crisis parciales o hallazgos de EEG indicativos de crisis parciales. Las mujeres en edad fertil deben poner en practivo un metodo anticonceptivo de acuerdo a los requisitos del protocolo.
The trial involves single site in the Member State concerned. Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial. Both Female Only Male Only. Committee on Advanced therapies CAT has issued a classification for this product.
Use of Felbamate or Vigabatrin within last 6 months? Title of the trial for lay people, in easily understood, clasificaicon.
Review by the Competent Authority or Ethics Committee in the country concerned. Clinical trials The European Union Clinical Trials Register allows you to search for protocol and results information on: Date on which this record was first entered in the EudraCT database:.
To demonstrate the efficacy of oral lacosamide LCM vs placebo as adjunctive therapy for uncontrolled primary generalized tonic-clonic PGTC seizures in subjects with idiopathic generalized epilepsy IGE currently taking 1 to 3 concomitant anti-epileptic claskficacion AEDs independent of the number of prior failed AEDs.
Periodo de Tratamiento de 24 semanas desde la Visita 2 Semana 0 a la Visita 10 semana Trials with results Trials without results.
Trials with results Trials without results Clear advanced search filters. How to search [pdf]. Combination product that includes a device, but does not involve an Advanced Therapy.
Regular use of neuroleptics, narcotics, monoamine oxidase MOA inhibitors, barbiturates for indication other than epilepsy within 28 days prior to Visit 1? Pneumonia AND sponsor name.
Women of child bearing potential must practice contraception according to protocol requirements?