Clinical trial NCT01051193: Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
Official title: A Multicentre, Open-label, Extension Study in Children With Inadequately Controlled Partial Onset Seizures to Investigate Long-term 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: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2010-01-18
Enrollment: 88
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to provide long term safety data of TRI476 in children with inadequately-controlled partial seizures. This study is conducted in patients who complete the core study CTRI476B1301. Blinding is maintained during the transition and dose adjustment phase of the extension study. All patients are treated with TRI476 from the dose adjustment phase onwards. The purpose of study is to confirm that TRI476 as adjunctive therapy is safe.


Eligibility criteria: Inclusion Criteria:

* Patients who completed the double-blind treatment phase of the core study (B1301).
* A parent/legal guardian must be present and give written consent for all patients enrolled in this trial. Patients consent must be obtained using assent document according to patients age.
* Females of childbearing potential must have a negative pregnancy test at Week 8 in the core study B1301.

Exclusion Criteria:

* Patients with medical ineligibility to enter the extension, as assessed by the investigator at each site.
* Patients who participated in the core study, but did not complete it (prematurely discontinued)

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG))
timeFrame: 52 weeks and until approval/launch
Secondary outcomes:
measure: Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period
timeFrame: 52 weeks and until approval/launch
measure: Seizure Frequency of specific duration
timeFrame: 52 weeks and until approval/launch
measure: Responder rate: defined as the proportion of patients with an at least 50% reduction in the partial epileptic seizure frequency
timeFrame: 52 weeks and until approval/launch
measure: Percent changes in the seizure frequency by subtype
timeFrame: 52 weeks and until approval/launch
measure: Clinical Global Impression of Change
timeFrame: 52 weeks and until approval/launch
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: NPC Investigative Site
state: Aichi
city: Obu-city
country: Japan
facility: NPC Investigative Site
state: Aichi
city: Matsuyama-city
country: Japan
facility: NPC Investigative Site
state: Ehime
city: Fukuoka-city
country: Japan
facility: NPC Investigative Site
state: Fukuoka
city: Kameda-gun
country: Japan
facility: NPC Investigative Site
state: Hokkaido
city: Sapporo-city
country: Japan
facility: NPC Investigative Site
state: Hokkaido
city: Himeji
country: Japan
facility: NPC Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: NPC Investigative Site
state: Hyogo
city: Yokohama
country: Japan
facility: NPC Investigative Site
state: Kanagawa
city: Koshi-city
country: Japan
facility: NPC Investigative Site
state: Kumamoto
city: Kashiwazaki
country: Japan
facility: NPC Investigative Site
state: Niigata
city: Yufu
country: Japan
facility: NPC Investigative Site
state: Oita
city: Kurashiki
country: Japan
facility: NPC Investigative Site
state: Okayama
city: Okayama-city
country: Japan
facility: NPC Investigative Site
state: Okayama
city: Neyagawa
country: Japan
facility: NPC Investigative Site
state: Osaka
city: Saitama-city
country: Japan
facility: NPC Investigative Site
state: Saitama
city: Moriyama-shi
country: Japan
facility: NPC Investigative Site
state: Shiga
city: Shizuoka-city
country: Japan
facility: NPC Investigative Site
state: Shizuoka
city: Shimotsuke-city
country: Japan
facility: NPC Investigative Site
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: NPC Investigative Site
state: Tokyo
city: Gifu
country: Japan
facility: NPC Investigative Site
city: Niigata
country: Japan
facility: NPC Investigative Site
city: Saitama
country: Japan
facility: NPC Investigative Site
city: Yamagata
country: Japan
facility: NPC Investigative Site
Study officials:
References: