Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: January 15, 2010
Last updated: October 28, 2013
Last verified: October 2013
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.
Partial Onset Seizures
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG)) [ Time Frame: 52 weeks and until approval/launch ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period [ Time Frame: 52 weeks and until approval/launch ] [ Designated as safety issue: No ]
- Seizure Frequency of specific duration [ Time Frame: 52 weeks and until approval/launch ] [ Designated as safety issue: No ]
- Responder rate: defined as the proportion of patients with an at least 50% reduction in the partial epileptic seizure frequency [ Time Frame: 52 weeks and until approval/launch ] [ Designated as safety issue: No ]
- Percent changes in the seizure frequency by subtype [ Time Frame: 52 weeks and until approval/launch ] [ Designated as safety issue: No ]
- Clinical Global Impression of Change [ Time Frame: 52 weeks and until approval/launch ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||May 2015 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||4 Years to 15 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01051193
|Bunkyo, Japan |
|Fukuoka, Japan |
|Kobe, Japan |
|Neyagawa, Japan |
|Okayama, Japan |
|Yokohama, Japan |
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 15, 2010
||October 28, 2013
||Japan: Ministry of Health, Labor and Welfare
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
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