Phase II BGG492 Capsule Extension for Partial Epilepsy | NCT01338805

NCT01338805

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2010-021448-17	EudraCT Number

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
BGG492	Experimental	hard gelatin capsule for oral administration at 50 mg TID, 100 mg TID or 150 mg TID	Drug: BGG492

Name	Type	Description	Arm Group Labels	Other Names
BGG492	Drug		BGG492

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
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.

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Tallahassee	Florida	32308	United States
Novartis Investigative Site

ID	Term
D009422	Nervous System Diseases
D002493	Central Nervous System Diseases
D001927	Brain Diseases
D009461	Neurologic Manifestations

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms