Clinical trial NCT01338805: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-04-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To evaluate the long-term safety and tolerability of BGG492 capsules during the maintenance period in patients suffering from partial onset seizures
timeFrame: 38 weeks
Secondary outcomes:
measure: 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.
timeFrame: 38 weeks
measure: 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.
timeFrame: 38 weeks
measure: 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.
timeFrame: 38 weeks
measure: 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.
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Novartis Investigative Site
state: Florida
city: Hamilton
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Bernau
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Kehl-Kork
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Kecskemet
country: Hungary
facility: Novartis Investigative Site
city: Szombathely
country: Hungary
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Warsaw
country: Poland
facility: Novartis Investigative Site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: