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-Onset Seizures
CompletadoFase 3ClinicalTrials.gov
ID: NCT01142193Tipo: INTERVENTIONALInicio: 1 de may de 2010Fin estimado: 1 de ene de 2013
The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
Elegibilidad
Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL
Criterios de inclusión
Subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to Visit 1.
Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to Visit 1 (12 weeks for phenobarbital and primidone).
Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline.
Criterios de exclusión
Have a history of seizure episodes lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished, within 3 months prior to Visit 1.
Have a history of pseudoseizures, or status epilepticus, within 3 months prior to Visit 1.
Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow angle glaucoma.
Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric illness within 2 years of Visit 1.
Currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past.
Have taken topiramate within the past 6 months.
Intervenciones
drug
USL255
drug
Placebo
Ubicaciones
Buenos Aires, Argentina
Córdoba, Argentina
Salta, Argentina
Villa Nueva, Argentina
Patrocinadores
PrincipalUpsher-Smith Laboratories
Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.
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