Phase II BGG492 Capsule Extension for Partial Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01338805
First received: April 15, 2011
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

This long-term extension study will assess the safety, tolerability and efficacy of BGG492 as adjunctive treatment in patients with partial onset seizures.


Condition Intervention Phase
Partial Onset Seizures
Drug: BGG492
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

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 [ Time Frame: 38 weeks ] [ Designated as safety issue: Yes ]

    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. [ Time Frame: 38 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: June 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGG492 Drug: BGG492

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338805

Locations
United States, Florida
Novartis Investigative Site
Tallahassee, Florida, United States, 32308
United States, New Jersey
Novartis Investigative Site
Hamilton, New Jersey, United States, 08619
United States, Texas
Novartis Investigative Site
Dallas, Texas, United States, 75230
Germany
Novartis Investigative Site
Bernau, Germany, 16321
Novartis Investigative Site
Bielefeld, Germany, 33617
Novartis Investigative Site
Bonn, Germany, 53105
Novartis Investigative Site
Kehl-Kork, Germany, 77694
Novartis Investigative Site
Ulm, Germany, 89081
Hungary
Novartis Investigative Site
Budapest, Hungary, 1096
Novartis Investigative Site
Kecskemet, Hungary, 6000
Novartis Investigative Site
Szombathely, Hungary, 9700
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 110 744
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 135-710
Poland
Novartis Investigative Site
Warsaw, Poland, 02-957
Slovakia
Novartis Investigative Site
Banska Bystrica, Slovakia, 97517
Novartis Investigative Site
Kosice, Slovakia, 041 90
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01338805     History of Changes
Other Study ID Numbers: CBGG492A2212, 2010-021448-17
Study First Received: April 15, 2011
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control

Keywords provided by Novartis:
Partial onset seizure
seizure frequency
nervous system diseases
central nervous system diseases
CNS
brain diseases
neurologic manifestations
adjunctive treatment
AEDs
antiepileptic drug

Additional relevant MeSH terms:
Epilepsies, Partial
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014