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

Primary Purpose

Partial Onset Seizures

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Investigational new drug, company code: BGG492
Placebo
Investigational new drug, company code: BGG492
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 Seizure frequency, nervous system diseases, 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 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

Sites / Locations

  • Barrow Neurological Clinics at St. Joseph's Hospital and MC
  • Center for Neurosciences
  • Clinical Trials, Inc.
  • Medical Center of the Rockies
  • AMO Corporation
  • Johns Hopkins Hospital
  • Investigative Site - Private Practice
  • St.John's Research Institute, Inc
  • Renown Institute for Neurosciences
  • NJ to Capital Health in Hamilton
  • Princeton and Rutgers Neurology
  • NYU Comprehensive Epilepsy Center
  • Thomas Jefferson University, Dept. of Psychiatry & Neurology
  • Neurological Clinic of Texas
  • 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
  • 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
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

BGG492 low dose

Placebo

BGG492 high dose

Arm Description

Outcomes

Primary Outcome Measures

To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.

Secondary Outcome Measures

To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period.
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.
Pharmacokinetic profile of BGG492

Full Information

First Posted
June 15, 2010
Last Updated
December 11, 2020
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01147003
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

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 and safety of BGG492 as adjunctive treatment in patients with 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
Seizure frequency, nervous system diseases, 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
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BGG492 low dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
BGG492 high dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Investigational new drug, company code: BGG492
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Investigational new drug, company code: BGG492
Primary Outcome Measure Information:
Title
To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period.
Time Frame
28 days
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.
Time Frame
12 weeks
Title
Pharmacokinetic profile of BGG492
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 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
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
Barrow Neurological Clinics at St. Joseph's Hospital and MC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Center for Neurosciences
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
Clinical Trials, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
AMO Corporation
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Investigative Site - Private Practice
City
Ocean Springs
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
Facility Name
St.John's Research Institute, Inc
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Renown Institute for Neurosciences
City
Reno
State/Province
Nevada
ZIP/Postal Code
89521
Country
United States
Facility Name
NJ to Capital Health in Hamilton
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
Princeton and Rutgers Neurology
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
NYU Comprehensive Epilepsy Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Thomas Jefferson University, Dept. of Psychiatry & Neurology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Neurological Clinic of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Bernau
ZIP/Postal Code
16321
Country
Germany
Facility Name
Novartis Investigative Site
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Novartis Investigative Site
City
Kehl-Kork
ZIP/Postal Code
77694
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
Country
Germany
Facility Name
Novartis Investigative SIte
City
Regensburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
Country
Germany
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Novartis Investigative Site
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Novartis Investigative Site
City
Bologna
ZIP/Postal Code
40123
Country
Italy
Facility Name
Novartis Investigative Site
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Novartis Investigative Site
City
Firenze
ZIP/Postal Code
50143
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
ZIP/Postal Code
40123
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Novartis Investigative Site
City
Venezia
ZIP/Postal Code
30122
Country
Italy
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
738-736
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Gdansk
ZIP/Postal Code
80-303
Country
Poland
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
31-209
Country
Poland
Facility Name
Novartis Investigative Site
City
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Novartis Investigative Site
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bratislava
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice
ZIP/Postal Code
041 90
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Zuerich
ZIP/Postal Code
8008
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Changhua
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Kaohsiung
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Lin-ko
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7124
Description
Results for CBGG492A2207 on the Novartis clinical trials website

Learn more about this trial

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

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