Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients with partial onset seizures.

Official Title
-----------------
A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study Examining Seizure Frequency of BGG492 Capsules as Adjunctive Treatment in Patients With Partial Onset Seizures

Conditions
-----------------
Partial Onset Seizures

Intervention / Treatment
-----------------
* Drug: Investigational new drug, company code: BGG492
* Drug: Placebo
* Drug: Investigational new drug, company code: BGG492


Participation Criteria
=================
Eligibility Criteria
-----------------
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 antiepileptic drugs (AEDs) within the last 2 years prior to screening. 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. Cohort 1 patients must be receiving stable treatment with 1 or a maximum of 2 AEDs.Cohort 2 patients must be receiving stable treatment with 1, 2, or 3 AEDs. 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. Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization. Pregnant or nursing (lactating) women. Other protocol-defined inclusion/exclusion criteria may apply

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGG492 low dose<br> | Drug: Investigational new drug, company code: BGG492<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Experimental: BGG492 high dose<br> | Drug: Investigational new drug, company code: BGG492<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period. |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period. |  | 28 days | 
| 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. |  | 12 weeks | 
| Pharmacokinetic profile of BGG492 |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AEDs, Seizure frequency, nervous system diseases, brain diseases, neurologic manifestations, adjunctive treatment, antiepileptic drug