Partial Onset Epilepsy Seizures
Conditions
Interventions
Product Name: Carisbamate
Pharmaceutical Form: Tablet
CAS Number: 194085-75-1
Current Sponsor code: RWJ-333369
Other descriptive name: (S)-2-O-carbamoyl-1-O-chlorophenyl-ethanol
Concentration unit: mg
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Man or woman aged 18 years or older, inclusive. 2. Weight of at least 35 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 6 simple partial motor, complex partial, or secondarily generalized seizures per 56 days, 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? no 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 or epilepsie partialis continua in 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 or 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: The primary efficacy endpoint to be evaluated for registration in the United States and the Rest of the World is the percent reduction from the pretreatment baseline phase in seizure frequency (average monthly seizure rate per 28 days) of all simple partial motor, complex partial, or secondarilygeneralized seizures relative to the double-blind treatment phase. The primary efficacy endpoint to be evaluated for registration in the countries of Europe, Australia, New Zealand and South Africa is the responder rate.;Secondary Objective: - Percent reduction in seizure frequency (average monthly seizure rate per 28 days) of all simple partial motor, complex partial, or secondarily generalized seizures during the double-blind treatment phase relative to the pretreatment baseline phase (only for registration in the countries of Europe, Australia, New Zealand and South Africa). - 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