Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2011-06-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BGG492
hard gelatin capsule for oral administration at 50 mg TID, 100 mg TID or 150 mg TID
BGG492
Interventions
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BGG492
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
66 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Countries
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Related Links
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Results for CBGG492A2212 from the Novartis Clinical Trials website
Other Identifiers
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2010-021448-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBGG492A2212
Identifier Type: -
Identifier Source: org_study_id
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