This long-term extension study will assess the safety, tolerability and efficacy of BGG492 as adjunctive treatment in patients with partial onset seizures.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Novartis Investigative Site
Tallahassee, Florida, United States
Novartis Investigative Site
Hamilton, New Jersey, United States
Novartis Investigative Site
To evaluate the long-term safety and tolerability of BGG492 capsules during the maintenance period in patients suffering from partial onset seizures
By measuring the number and percent of patients having any AE (advent event) by primary system organ class and/or preferred term. By laboratory, vital sign, and ECG data, summary statistics of values and change from baseline
Time frame: 38 weeks
To evaluate the efficacy over time by the change in partial seizure frequency original Baseline Period in the double-blind study CBGG492A2207 to the Open-label Extension Maintenance Phase.
Time frame: 38 weeks
Responder rate: To evaluate the maintenance of efficacy by the change in responder rate and numbers of patients becoming seizure free from the original Baseline Period to the Open-label Extension Maintenance Phase.
Time frame: 38 weeks
Seizure counts: To evaluate the maintenance of efficacy and safety as assessed in percent change of seizure frequency of BGG492 capsules from the original Baseline Period to the Open-label Extension Maintenance Phase.
Time frame: 38 weeks
To evaluate long-term efficacy and safety by summarizing the number and percentage of patients who discontinue due to unsatisfactory therapeutic response effect and for all other reasons.
Time frame: 30 weeks
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Dallas, Texas, United States
Novartis Investigative Site
Bernau, Germany
Novartis Investigative Site
Bielefeld, Germany
Novartis Investigative Site
Bonn, Germany
Novartis Investigative Site
Kehl-Kork, Germany
Novartis Investigative Site
Ulm, Germany
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Kecskemét, Hungary
...and 6 more locations