A multicenter, open-label, follow-up study to evaluate the long-term safety and tolerability of BGG492 TID as adjunctive therapy in patients with partial onset seizures completing double-blind, placebo-controlled study CBGG492A2207 or CBGG492A2211. - not available
- Conditions
- Epilepsy Partial onset seizures
- Registration Number
- EUCTR2010-021448-17-SK
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 62
• Male and female outpatients age 18 to 66 years (inclusive) with weight of = 45 Kg (99 lb);
• Completed the 10-week Double-blind Treatment Evaluation Phase plus one week of dose-tapering (Visit 9, Day 78) in study CBGG492A2207, have cooperated with the study procedures and have not experienced persistent tolerability issues;
• Patients who wish to continue BGG492 treatment and from whom the investigator believes a reasonable benefit from the long-term administration of BGG492 may be expected;
• Are currently treated with a stable dose of one or a maximum of three licensed AEDs and are known to take their medication(s) as directed;
• Provided written informed consent before any extension assessment is performed.
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
• History of status epilepticus or seizure clusters occurring during Study CBGG492A2207 or in the period between the end of study CBGG492A2207 and the start of study CBGG492A2212 for patients experiencing a treatment gap.
• Patients who have been treated with:
• Felbamate, unless treatment has been continuous for = 2 years;
• Vigabatrin during 26 weeks prior to the first dose of open-label medication in the extension study;
• Monoamine oxidase (MAO) inhibitors, tricyclic-antidepressants and narcotic analgesics such as e.g. morphine, oxycodone, fentanyl, codeine within 8 weeks prior to the first dose of openlabel medication in the extension study;
• L-Dopa formulations;
• Used concomitant medication that are potential inhibitors of OATP transporters e.g.
cyclosporine, rifampin, fluvastatine, fexofenadine 8 weeks prior to the first dose of open-label medication in the extension study.
• No physical examination changes suggestive of progressive neurological changes (e.g. Alzheimer’s disease, Parkinson’s Disease, Multiple Sclerosis) during Study CBGG492A2207;
• History of hypersensitivity to the study drug or to drugs of similar chemical classes (e.g. sulfonamides);
• Pregnant or lactating females.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective is to evaluate the long-term safety, tolerability and efficacy data for BGG492 at oral doses of 20mg, 50mg, 100mg TID administered as adjunctive therapy in adult patients with partial onset seizures. seizures as required by regulatory guidelines. ;Secondary Objective: • To evaluate the maintenance of efficacy over time as assessed by the change in partial seizure frequency from the original Baseline Period (28 days) in the double-blind study CBGG492A2207 to the Open-label Extension Maintenance Phase;<br>• To evaluate the maintenance of efficacy over time as assessed by the change in responder rate and numbers of patients becoming seizure free from the Baseline Period in study CBGG492A2207 to the Open-label Extension Maintenance Phase;<br>• To evaluate long-term efficacy and safety by summarizing the number and percentage of patients who discontinue due to unsatisfactory therapeutic effect and all other reasons .<br>;Primary end point(s): Seizure frequency and seizure types.
- Secondary Outcome Measures
Name Time Method