Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–66
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
