Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures

Study Overview
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Brief Summary
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This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory partial onset seizures

Official Title
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A 12-week, Randomized, Double-blind, Placebo-controlled Exploratory Study to Assess the Antiepileptic Activity of BGG492 Given Orally as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures

Conditions
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Partial Onset Seizures

Intervention / Treatment
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* Drug: BGG492
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGG492<br> | Drug: BGG492<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period. |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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partial onset seizure, seizure frequency, nervous system diseases, central nervous system diseases, CNS, brain diseases, neurologic manifestations, adjunctive treatment, AEDs, antiepileptic drug