Epilepsy with partial onset seizures MedDRA version: 9.1 Level: LLT Classification code 10015037 Term: Epilepsy
Conditions
Sponsors
Janssen Cilag International, NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Must have completed the 14-week double-blind treatment phase of study CARISEPY3013 · Willing/able to follow the prohibitions and restrictions specified in this protocol · Willing/able to complete the subject diaries correctly (subjects or legally acceptable representatives) · Subjects (or their legally acceptable representatives) must have signed an informed consent form indicating that they understand the purpose of and the procedures required for the open-label extension study CARISEPY3014 and are willing to participate in this study. Assent is also required of adolescents capable of understanding the nature of the study, as described in the protocol. Note: Subjects with cognitive impairment may be enrolled in this study. The investigator will determine each subject’s capacity to provide informed consent. When cognitive impairment brings a subject’s capacity into question, the investigator will obtain informed consent and assent from the cognitively impaired subject, and consent from the legally acceptable representative(s) in accordance with all applicable local regulations. 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: Potential subjects must be willing/able to adhere to the following prohibitions and restrictions during the course of the study to be eligible for participation: · Must not start any herbal supplements as specified in Attachment 7; the use of all other herbal supplements during the double-blind treatment phase and the open-label extension study must be approved by the sponsor’s medical officer · Must not start any drugs that are known to cause seizures · Must not take acetaminophen (paracetamol) in dosages greater than 1,000 mg/day; periodic use of acetaminophen up to 2,500 mg/day will be allowed throughout the study · Women must remain on an effective method of birth control (see inclusion criteria)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is: · To obtain long-term safety and tolerability data on subjects with partial onset seizures treated with open-label carisbamate ;Primary end point(s): ;Secondary Objective: The exploratory objectives of this study are: · To evaluate the impact of carisbamate on subject functioning and well-being using the QOLIE-31 Patient Inventory after 3 months of treatment with open-label carisbamate · To collect MRU data that may be used in future economic modeling (the construction and reporting of the economic model will be conducted separately from this study) | — |
Countries
Lithuania
Outcome results
None listed