Partial Onset Epilepsy Seizures MedDRA version: 8.1 Level: LLT Classification code 10015037 Term: Epilepsy
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.
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): 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. | — |
Countries
Czech Republic, Finland, Germany, Sweden
Outcome results
None listed