Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
NCT ID: NCT00975715
Last Updated: 2014-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
99 participants
INTERVENTIONAL
2009-09-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TRI476
Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
TRI476
TRI476 oral suspension doses, based on body weight twice daily
Benzodiazepines
Benzodiazepines could be used as needed as rescue medication during the duration of the study.
Placebo
Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
Placebo to TRI476
Placebo oral suspension, taken twice daily
Benzodiazepines
Benzodiazepines could be used as needed as rescue medication during the duration of the study.
Interventions
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TRI476
TRI476 oral suspension doses, based on body weight twice daily
Placebo to TRI476
Placebo oral suspension, taken twice daily
Benzodiazepines
Benzodiazepines could be used as needed as rescue medication during the duration of the study.
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of partial onset seizures, which include the seizure subtypes of simple, complex, and secondarily generalized seizures (based on the International League Against Epilepsy (ILAE) Classification, as modified in 1981).
Exclusion Criteria
* Seizures having a metabolic, neoplastic, or active infectious origin.
4 Years
14 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
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Ohbu, Aichi-ken, Japan
Novartis Investigative Site
Matsuyama, Ehime, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Gifu, Gifu, Japan
Novartis Investigative Site
Kameda-gun, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Himeji, Hyōgo, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Kōshi, Kumamoto, Japan
Novartis Investigative Site
Kashiwazaki, Niigata, Japan
Novartis Investigative Site
Niigata, Niigata, Japan
Novartis Investigative Site
Yufu, Oita Prefecture, Japan
Novartis Investigative Site
Kurashiki, Okayama-ken, Japan
Novartis Investigative Site
Okayama, Okayama-ken, Japan
Novartis Investigative Site
Neyagawa, Osaka, Japan
Novartis Investigative Site
Higashimatsuyama-shi, Saitama, Japan
Novartis Investigative Site
Saitama, Saitama, Japan
Novartis Investigative Site
Moriyama-shi, Shiga, Japan
Novartis Investigative Site
Shizuoka, Shizuoka, Japan
Novartis Investigative Site
Shimotsuke, Tochigi, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan
Novartis Investigative Site
Yamagata, Yamagata, Japan
Novartis Investigative Site
Chūō, Yamanashi, Japan
Countries
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Related Links
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Other Identifiers
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CTRI476B1301
Identifier Type: -
Identifier Source: org_study_id
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