Clinical trial NCT00975715: Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
Official title: A Multicentre, Randomized, Double-blind, Placebo Controlled, Parallel-group Study in Children With Inadequately Controlled Partial Onset Seizures to Investigate Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) as Adjunctive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Partial Onset Seizures
Keywords: Seizures
oxcarbazepine
child
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 99
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks. The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.


Eligibility criteria: Inclusion Criteria:

* Male and female outpatients, aged 4 to 14 years (inclusive), with a minimum body weight of 15 kg.
* 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:

* A document history of generalized status epileptics in the past 6 months.
* Seizures having a metabolic, neoplastic, or active infectious origin.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group
timeFrame: screening and 28 days
Secondary outcomes:
measure: Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group
timeFrame: baseline, 28 days and 56 days
measure: Percent of Participants With Response During Double-blind Phase, by Treatment Group
timeFrame: screening to 28 days
measure: Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type
timeFrame: 28 days
measure: Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group
timeFrame: 56 days
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Ohbu
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Matsuyama
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kameda-gun
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Himeji
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Koshi-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kashiwazaki
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Yufu
country: Japan
facility: Novartis Investigative Site
state: Oita
city: Kurashiki
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Neyagawa
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Higashimatsuyama-shi
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Moriyama-shi
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Shimotsuke-city
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-city
country: Japan
facility: Novartis Investigative Site
state: Yamanashi
city: Gifu
country: Japan
facility: Novartis Investigative Site
city: Niigata
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Shizuoka
country: Japan
facility: Novartis Investigative Site
city: Yamagata
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: