An Extension Study of Safety and Tolerability of BGG492 Adjunctive Therapy in Patients With Partial Onset Seizures



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:June 2011
End Date:August 2012
Contact:Novartis Pharmaceuticals
Phone:862-778-8300

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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


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


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
We found this trial at
10
sites
Dallas, Texas 75230
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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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Fort Collins, Colorado 80528
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Hamilton, New Jersey 08873
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New York, New York 10016
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Ocean Springs, Mississippi 39564
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Philadelphia, PA
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Tallahassee, Florida 32308
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