Partial Onset Seizures
Conditions
Keywords
partial onset seizure, seizure frequency, nervous system diseases, central nervous system diseases, CNS, brain diseases, neurologic manifestations, adjunctive treatment, AEDs, antiepileptic drug
Brief summary
This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory partial onset seizures
Interventions
DRUGBGG492
DRUGPlacebo
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Outpatients ≥ 50 kg (110 lb) of weight * A diagnosis of epilepsy (≥ 2 years prior to screening) with partial seizures with or without secondarily generalized seizures * Uncontrolled partial seizures despite having been treated with at least two different AEDs within the last 2 years prior to screening. * Treated with a stable dose of 1-2 AEDs * At least 4 partial seizures during the 4-week baseline period and at least 4 partial seizures during the 4 weeks prior to the baseline period. * No 28-day seizure-free period during the 8 weeks preceding randomization * Positive biomarker screening
Exclusion criteria
* Presence of only non-motor simple partial seizures * History of psychogenic seizures * Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy; * Previous history of Lennox-Gastaut syndrome * Pregnant or nursing (lactating) women * Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period. | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period. | 28 days |
| Safety and tolerability of BGG492 compared to placebo evaluated by continuous adverse event monitoring and assessment of vital signs and ECGs at each visit and laboratory assessments every 2 to 4 weeks | 12 weeks |
| Pharmacokinetic profile of BGG492 including plasma concentrations of BGG492 at each dose level and derived variables including AUC (area under the curve), Cmax (maximum plasma concentration), Tmax (time to maximum concentration), T1/2 (half life.) | 10 weeks |
Countries
Austria, Belgium, Bulgaria, Canada, Estonia, India, Latvia, Lithuania, Romania, Spain, United States
Outcome results
None listed