Partial Onset Epilepsy Seizures
Conditions
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. 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
Exclusion criteria
Exclusion criteria: 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. Change in frequency of partial onset seizures during the pre-treatment baseline phase and during the double-blind treatment phase. Subject diaries will be the source of all seizure data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Percent reduction in seizure frequency (average monthly seizure rate per 28 days) of all simple partial motor and/or complex partial, and/or secondarily generalized seizures during the double-blind treatment phase, relative to the pre-treatment phase;Secondary Objective: Proportion of subjects with > 50% reduction from the pre-treatment baseline phase in seizure frequency. - Change relative to baseline in the Recovery (after seizures) composite score of the SSQ compared to the end of the double-blind treatment phase. - Changes in overall and subscale scores of various outcome scales;Primary end point(s): The primary objective of this study is to determine the efficacy, safety and tolerability of RWJ-333369 as adjunctive treatment of partial onset seizure. The primary efficacy endpoint to be evaluated is the percent reduction from the pretreatment baseline phase in seizure frequency (average monthly seizure rate per 28 days) of all simple partial motor, and/or complex partial, and/or secondarily generalized seizures compared to the double-blind treatment phase. | — |
Countries
Denmark, Hungary
Outcome results
None listed