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

Primary Purpose

Partial Onset Seizures

Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BGG492
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Onset Seizures focused on measuring partial onset seizure, seizure frequency, nervous system diseases, central nervous system diseases, CNS, brain diseases, neurologic manifestations, adjunctive treatment, AEDs, antiepileptic drug

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Alabama
  • Johns Hopkins Hospital
  • Epilepsy Care Specialists, S.C.
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigational Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BGG492

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.

Secondary Outcome Measures

Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.
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
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.)

Full Information

First Posted
June 25, 2010
Last Updated
April 30, 2012
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01167335
Brief Title
Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Withdrawn
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Onset Seizures
Keywords
partial onset seizure, seizure frequency, nervous system diseases, central nervous system diseases, CNS, brain diseases, neurologic manifestations, adjunctive treatment, AEDs, antiepileptic drug

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BGG492
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BGG492
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.
Time Frame
28 days
Title
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
Time Frame
12 weeks
Title
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.)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Epilepsy Care Specialists, S.C.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Novartis Investigative Site
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
Novartis Investigative Site
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Novartis Investigational Site
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Novartis Investigative Site
City
Duffel
ZIP/Postal Code
2570
Country
Belgium
Facility Name
Novartis Investigative Site
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Novartis Investigative Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Novartis Investigative Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Novartis Investigative Site
City
Dehli
State/Province
New Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
Novartis Investigative Site
City
Jaipur
ZIP/Postal Code
302004
Country
India
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Novartis Investigative Site
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
011635
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
024092
Country
Romania
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

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

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