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

psher-Smith Laboratories, Inc.0 个研究点目标入组 334 人开始时间: 2010年4月20日最近更新: 2014年1月27日

适应症

试验速览

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•Subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to Visit 1. The diagnosis of partial-onset seizures with or without secondary generalized seizure is defined by the ILAE commission in 1981.
•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).
•oNote: VNS can be counted as one of the AEDs provided the VNS has been in place for at least 6 months and on a stable setting for at least 1 month prior to Visit 1. The VNS settings must not change throughout the course of the study (baseline, titration, and maintenance phases).
•oNote: Benzodiazepines (BZD) taken more than once per week, for any indication, will be counted as one of the AEDs.
•Male or female, aged 18 to 75 years, inclusive.
•Can safely be treated, in the opinion of the investigator, with topiramate
•Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline.
•oNote: Only simple partial seizures with motor signs, complex partial seizures, and partial seizures with secondary generalization are counted toward this inclusion.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 284
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•Have a predisposing condition or medications that may interfere with the absorption of USL255. For example, Crohn’s disease, ileostomy, short bowel syndrome, chronic diarrhea.
•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.
•Have taken topiramate within the past 6 months.
•History of lack of efficacy to topiramate, for epilepsy, despite adequate exposure (200mg/day)
•History of safety or tolerability issues to topiramate not related to dosage titration
•Currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past.

发起方

psher-Smith Laboratories, Inc.