Phase II BGG492 Capsule Extension for Partial Epilepsy

Partial Onset Seizures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338805
• Other study ID #: CBGG492A2212
• Secondary ID: 2010-021448-17
• Status: Completed
• Phase: Phase 2
• Start date: June 2011
• Est. completion date: July 2012

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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

Related Conditions & MeSH terms

• Partial Onset Seizures
• Seizures

Intervention

Drug:
• BGG492

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Bernau
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Kehl-Kork
Germany	Novartis Investigative Site	Ulm
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Kecskemet
Hungary	Novartis Investigative Site	Szombathely
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Poland	Novartis Investigative Site	Warsaw
Slovakia	Novartis Investigative Site	Banska Bystrica
Slovakia	Novartis Investigative Site	Kosice
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Hamilton	New Jersey
United States	Novartis Investigative Site	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  Korea, Republic of,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	38 weeks
Secondary	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.		38 weeks
Secondary	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.		38 weeks
Secondary	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.		38 weeks
Secondary	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.		30 weeks

External Links

•   Results for CBGG492A2212 from the Novartis Clinical Trials website