Epilepsy Partial onset seizures MedDRA version: 12.1 Level: LLT Classification code 10065336 Term: Partial epilepsy
Conditions
Interventions
Product Name: not available
Product Code: BGG492A
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: BGG492A
Current Sponsor code: BGG492A
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have completed 10 week double-blind treatment evaluation Phase plus one week of dose-tapering in study 2207 or 2211, have cooperated in study procedures and have been perceived by investigator as deriving benefit from taking the study medication without experiencing tolerability issues. - patients who wish to continue BGG492 treatment - male and female outpatients age 18 to 66 Years (inclusive) - weight sup or equal to 45kg - are currently treated with a stable dose of 1 or max 2 licensed AEDs - are reliable - have provided written informed consent 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: - history of status epilepticus or seizure clusters occuring during study 2207 or 2211 - patients with a planned brain surgery in the next 6 months - no physical examination changes suggestive of progressive neurological changes (AD, PD, MS) - patients who received prohibited medication or used benzodiazepines intermittently during the double-blind studies - history of hypersensitivity to study drug or to drugs of similar chemical classes - etc....
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. The total daily dose of BGG492 administered during the study will be 60mg, 150mg or 300mg depending on the patient tolerability.;Secondary Objective: - evaluate 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 studies BGG492A2207 and BGG492A2211 to the Open-label Extension Maintenance Phase - evaluate maintenance of efficacy over time as assessed by the change in responder rate and numbers of patients becoming seizure free from the Baseline Period (28 days) in the double-blind studies BGG492A2207 and BGG492A2211 to the Open-label Extension Maintenance Phase - evaluate long-term efficacy - evaluate PK, plasma levels of concomitant AEDs, number of seizures during BGG tapering off, QoL and the total HADS score. ;Primary end point(s): Seizure frequency and seizure types | — |
Countries
Germany, Hungary, Slovakia
Outcome results
None listed