Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures

Phase 2

Completed

• Conditions: Partial Onset Seizures
• Interventions: Drug: Oxcarbazepine

• Registration Number: NCT01051193
• Lead Sponsor: Nobelpharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-05
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRI476	Oxcarbazepine	TRI476

Primary Outcome Measures

Name	Time	Method
Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG))	52 weeks and until approval/launch

Secondary Outcome Measures

Name	Time	Method
Seizure Frequency of specific duration	52 weeks and until approval/launch
Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period	52 weeks and until approval/launch
Responder rate: defined as the proportion of patients with an at least 50% reduction in the partial epileptic seizure frequency	52 weeks and until approval/launch
Percent changes in the seizure frequency by subtype	52 weeks and until approval/launch
Clinical Global Impression of Change	52 weeks and until approval/launch

Trial Locations

Locations (1)

NPC Investigative Site; 🇯🇵 Yamagata, Japan