Phase II BGG492 Capsule Extension for Partial Epilepsy

Completed · Phase 2

Conditions studied: Partial Onset Seizures

In brief

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

Key facts

Study ID

NCT01338805

Run by

Novartis Pharmaceuticals

People needed

56

Starts

2011-06-01

Expected to finish

2012-07-01

Last updated by the study team

2021-03-05

Who can join

Age: 18 and older, up to 66. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Tallahassee, Florida, United States
• Novartis Investigative Site — Hamilton, New Jersey, United States
• Novartis Investigative Site — Dallas, Texas, United States
• 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, Germany
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Kecskemét, Hungary
• Novartis Investigative Site — Szombathely, Hungary
• Novartis Investigative Site — Warsaw, Poland
• Novartis Investigative Site — Banská Bystrica, Slovakia
• Novartis Investigative Site — Košice, Slovakia
• Novartis Investigative Site — Seoul, Korea, South Korea
• Novartis Investigative Site — Seoul, Korea, South Korea

Full record on ClinicalTrials.gov

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