An open label study to evaluate the efficacy, safety and tolerability of RWJ333369 as adjunctive therapy in subjects with partial onset seizure

Janssen-Cilag International N.V.0 个研究点目标入组 510 人开始时间: 2007年6月4日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•For the double blind trial 3002:
•1. Male or female aged 16 years or older, inclusive. 2. Weight of at least 40 kg. 3. Established diagnosis of partial epilepsy for at least 1 year, using ILAE criteria. 4. History of inadequate response to at least 1 AED. 5. Current treatment with at least 1 and no more than 2 AED's. 6. Have had at least 3 simple partial motor, complex partial, or secondarily generalized seizures per month, and no seizure-free interval for more than 3 weeks. 6. Post-menopausal females, or those using acceptable method of birth control.
•Inclusion criteria for study 3004:
•subject must complete the 12-week double-blind treatment phase of study 333369-EPY-3002
•subject must have signed a separate informed consent form for open-label extension study (333369-EPY-3004)
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. History of status epilepticus within 6 months before study entry. 2. Generalized epileptic syndrome or having only absence, atonic/tonic, or simple partial sensory or other simple partial type seizures. 3. Lennox-Gastaut Syndrome 4. Current serious or medically unstable systemic diseases. 5. Current major depression, or history of suicide within last 2 years. 6. History of drug or alcohol abuse. 7. Positive for hepatitis B or C, or HIV/AIDS. 8. History of drug-induced liver injury, or diagnosis of any form of chronic liver disease.

发起方