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Phase II BGG492 Capsule Extension for Partial Epilepsy

Primary Purpose

Partial Onset Seizures

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BGG492
Sponsored by
Novartis Pharmaceuticals
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 - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Completed study CBGG492A2207, cooperated with the study procedures and did not experience persistent tolerability issues
  • Outpatients ≥ 45 kg (99 lb) of weight
  • Patient would like to continue BGG492 treatment and the investigator believes a reasonable benefit from the long-term administration of BGG492 may be expected
  • Treated with a stable dose of one or a maximum of three licensed Antiepileptic drugs (AEDs)and are known to take their medication(s) as directed
  • Will make themselves available for the study period and are able to record seizures and report adverse events themselves or have a caregiver who can record and report the events
  • Provided written informed consent before any extension assessment is performed

Exclusion Criteria:

  • Status epilepticus or seizure clusters occurring during study CBGG492A2207 or in the period between the end of study the double blind study and the start of study CBGG492A2212 for patients experiencing a treatment gap
  • Have been treated with:
  • Felbamate, unless treatment has been continuous for ≥ 2 years
  • Vigabatrin during the 26 weeks prior to the first dose of open-label medication in the extension study
  • Monoamine oxidase (MAO) inhibitors, tricyclic-antidepressants and narcotic analgesics
  • L-Dopa formulations
  • Use of concomitant medication that are potential inhibitors of Organic anion-transporting polypeptide (OATP) transporters
  • No physical examination changes suggestive of progressive neurological changes during Study CBGG492A2207
  • Used another investigational drug (other than BGG492) either at the time of enrollment in this extension study or within 5 half-lives prior to enrollment in this extension study
  • History of hypersensitivity to the study drug or to drugs of similar chemical classes (e.g. sulfonamides) or had multiple drug allergies or one or more severe drug reactions to an Antiepileptic drugs (AEDs), including dermatological reactions
  • Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • 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 Type

Experimental

Arm Label

BGG492

Arm Description

hard gelatin capsule for oral administration at 50 mg TID, 100 mg TID or 150 mg TID

Outcomes

Primary Outcome Measures

To evaluate the long-term safety and tolerability of BGG492 capsules during the maintenance period in patients suffering from partial onset seizures
By measuring the number and percent of patients having any AE (advent event) by primary system organ class and/or preferred term. By laboratory, vital sign, and ECG data, summary statistics of values and change from baseline

Secondary Outcome Measures

To evaluate the efficacy over time by the change in partial seizure frequency original Baseline Period in the double-blind study CBGG492A2207 to the Open-label Extension Maintenance Phase.
Responder rate: To evaluate the maintenance of efficacy by the change in responder rate and numbers of patients becoming seizure free from the original Baseline Period to the Open-label Extension Maintenance Phase.
Seizure counts: To evaluate the maintenance of efficacy and safety as assessed in percent change of seizure frequency of BGG492 capsules from the original Baseline Period to the Open-label Extension Maintenance Phase.
To evaluate long-term efficacy and safety by summarizing the number and percentage of patients who discontinue due to unsatisfactory therapeutic response effect and for all other reasons.

Full Information

First Posted
April 15, 2011
Last Updated
March 2, 2021
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01338805
Brief Title
Phase II BGG492 Capsule Extension for Partial Epilepsy
Official Title
A Multicenter, Open-label, Follow-up Study to Evaluate the Long-term Safety and Tolerability of BGG492 TID as Adjunctive Therapy in Patients With Partial Onset Seizures Completing Double-blind, Placebo-controlled Study CBGG492A2207 or CBGG492A2211
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This long-term extension study will assess the safety, tolerability and efficacy 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
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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BGG492
Arm Type
Experimental
Arm Description
hard gelatin capsule for oral administration at 50 mg TID, 100 mg TID or 150 mg TID
Intervention Type
Drug
Intervention Name(s)
BGG492
Primary Outcome Measure Information:
Title
To evaluate the long-term safety and tolerability of BGG492 capsules during the maintenance period in patients suffering from partial onset seizures
Description
By measuring the number and percent of patients having any AE (advent event) by primary system organ class and/or preferred term. By laboratory, vital sign, and ECG data, summary statistics of values and change from baseline
Time Frame
38 weeks
Secondary Outcome Measure Information:
Title
To evaluate the efficacy over time by the change in partial seizure frequency original Baseline Period in the double-blind study CBGG492A2207 to the Open-label Extension Maintenance Phase.
Time Frame
38 weeks
Title
Responder rate: To evaluate the maintenance of efficacy by the change in responder rate and numbers of patients becoming seizure free from the original Baseline Period to the Open-label Extension Maintenance Phase.
Time Frame
38 weeks
Title
Seizure counts: To evaluate the maintenance of efficacy and safety as assessed in percent change of seizure frequency of BGG492 capsules from the original Baseline Period to the Open-label Extension Maintenance Phase.
Time Frame
38 weeks
Title
To evaluate long-term efficacy and safety by summarizing the number and percentage of patients who discontinue due to unsatisfactory therapeutic response effect and for all other reasons.
Time Frame
30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed study CBGG492A2207, cooperated with the study procedures and did not experience persistent tolerability issues Outpatients ≥ 45 kg (99 lb) of weight Patient would like to continue BGG492 treatment and the investigator believes a reasonable benefit from the long-term administration of BGG492 may be expected Treated with a stable dose of one or a maximum of three licensed Antiepileptic drugs (AEDs)and are known to take their medication(s) as directed Will make themselves available for the study period and are able to record seizures and report adverse events themselves or have a caregiver who can record and report the events Provided written informed consent before any extension assessment is performed Exclusion Criteria: Status epilepticus or seizure clusters occurring during study CBGG492A2207 or in the period between the end of study the double blind study and the start of study CBGG492A2212 for patients experiencing a treatment gap Have been treated with: Felbamate, unless treatment has been continuous for ≥ 2 years Vigabatrin during the 26 weeks prior to the first dose of open-label medication in the extension study Monoamine oxidase (MAO) inhibitors, tricyclic-antidepressants and narcotic analgesics L-Dopa formulations Use of concomitant medication that are potential inhibitors of Organic anion-transporting polypeptide (OATP) transporters No physical examination changes suggestive of progressive neurological changes during Study CBGG492A2207 Used another investigational drug (other than BGG492) either at the time of enrollment in this extension study or within 5 half-lives prior to enrollment in this extension study History of hypersensitivity to the study drug or to drugs of similar chemical classes (e.g. sulfonamides) or had multiple drug allergies or one or more severe drug reactions to an Antiepileptic drugs (AEDs), including dermatological reactions 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
Novartis Investigative Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Novartis Investigative Site
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08619
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
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
53105
Country
Germany
Facility Name
Novartis Investigative Site
City
Kehl-Kork
ZIP/Postal Code
77694
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89081
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
Seoul
State/Province
Korea
ZIP/Postal Code
110 744
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
135-710
Country
Korea, Republic of
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
97517
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice
ZIP/Postal Code
041 90
Country
Slovakia

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9223
Description
Results for CBGG492A2212 from the Novartis Clinical Trials website

Learn more about this trial

Phase II BGG492 Capsule Extension for Partial Epilepsy

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