Phase II BGG492 Capsule Extension for Partial Epilepsy

Novartis

Status and phase: Completed; Phase 2

Conditions: Partial Onset Seizures

Treatments: Drug: BGG492

Study type: Interventional

Funder types: Industry

Identifiers

NCT01338805

CBGG492A2212

2010-021448-17 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 18 to 66 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

BGG492

Experimental group

Description:

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

Treatment:

Drug: BGG492