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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Partial Onset Seizures
• Intervention / Treatment: Drug: Placebo; Drug: BGG492

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, A-5020
    • Novartis Investigative Site
  • Vienna, Austria, 1090
    • Novartis Investigative Site
  • Wien, Austria, 1130
    • Novartis Investigational site
• Belgium
  • Duffel, Belgium, 2570
    • Novartis Investigative Site
  • Ottignies, Belgium, 1340
    • Novartis Investigative Site
• Bulgaria
  • Sofia, Bulgaria, 1113
    • Novartis Investigative Site
• Canada
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H2L 4M1
      • Novartis Investigative Site
• Estonia
  • Tallinn, Estonia, 10617
    • Novartis Investigative Site
  • Tartu, Estonia, 51014
    • Novartis Investigative Site
• India
  • Jaipur, India, 302004
    • Novartis Investigative Site
  • Karnataka
    • Bangalore, Karnataka, India, 560054
      • Novartis Investigative Site
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Novartis Investigative Site
  • New Delhi
    • Dehli, New Delhi, India, 110002
      • Novartis Investigative Site
• Latvia
  • Riga, Latvia, LV-1038
    • Novartis Investigative Site
  • Riga, Latvia, 1002
    • Novartis Investigative Site
• Lithuania
  • Kaunas, Lithuania, 50009
    • Novartis Investigative Site
• Romania
  • Bucharest, Romania, 011635
    • Novartis Investigative Site
  • Bucharest, Romania, 024092
    • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08036
    • Novartis Investigative Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36693
      • University Of South Alabama
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Epilepsy Care Specialists, S.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: BGG492	Drug: BGG492

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: June 25, 2010
• First Submitted That Met QC Criteria: July 20, 2010
• First Posted (Estimate): July 22, 2010

Study Record Updates

• Last Update Posted (Estimate): May 1, 2012
• Last Update Submitted That Met QC Criteria: April 30, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: nervous system diseases; CNS; brain diseases; adjunctive treatment; antiepileptic drug; central nervous system diseases; seizure frequency; neurologic manifestations; AEDs; partial onset seizure
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: CBGG492A2211; 2010-018766-23 (EudraCT Number)