NCT01051193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_2

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

9.7 years

First QC Date

January 15, 2010

Last Update Submit

November 14, 2019

Conditions

Partial Onset Seizures

Keywords

Seizuresoxcarbazepinechild

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG))

    52 weeks and until approval/launch

Secondary Outcomes (5)

  • 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

  • Seizure Frequency of specific duration

    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

Study Arms (1)

TRI476

EXPERIMENTAL

TRI476

Drug: Oxcarbazepine

Interventions

OxcarbazepineDRUG
TRI476

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

NPC Investigative Site

Nagoya, Aichi-ken, 460-0004, Japan

Location

NPC Investigative Site

Ōbu, Aichi-ken, 474-8710, Japan

Location

NPC Investigative Site

Matsuyama, Ehime, 790-8524, Japan

Location

NPC Investigative Site

Fukuoka, Fukuoka, 814-0180, Japan

Location

NPC Investigative Site

Kameda-gun, Hokkaido, 041-1111, Japan

Location

NPC Investigative Site

Sapporo, Hokkaido, 060-8648, Japan

Location

NPC Investigative Site

Himeji, Hyōgo, 670-8540, Japan

Location

NPC Investigative Site

Kobe, Hyōgo, 658-0032, Japan

Location

NPC Investigative Site

Yokohama, Kanagawa, 244-0842, Japan

Location

NPC Investigative Site

Kōshi, Kumamoto, 861-1196, Japan

Location

NPC Investigative Site

Kashiwazaki, Niigata, 945-8585, Japan

Location

NPC Investigative Site

Yufu, Oita Prefecture, 879-5593, Japan

Location

NPC Investigative Site

Kurashiki, Okayama-ken, 710-8522, Japan

Location

NPC Investigative Site

Okayama, Okayama-ken, 700-8558, Japan

Location

NPC Investigative Site

Neyagawa, Osaka, 572-0085, Japan

Location

NPC Investigative Site

Saitama, Saitama, 330-8777, Japan

Location

NPC Investigative Site

Moriyama-shi, Shiga, 524-0022, Japan

Location

NPC Investigative Site

Shizuoka, Shizuoka, 420-8688, Japan

Location

NPC Investigative Site

Shimotsuke, Tochigi, 329-0498, Japan

Location

NPC Investigative Site

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

NPC Investigative Site

Gifu, 502-8558, Japan

Location

NPC Investigative Site

Niigata, 950-2085, Japan

Location

NPC Investigative Site

Saitama, 355-0008, Japan

Location

NPC Investigative Site

Yamagata, 990-0876, Japan

Location

MeSH Terms

Conditions

Seizures

Interventions

Oxcarbazepine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CarbamazepineDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

January 5, 2010

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

November 15, 2019

Record last verified: 2019-11

Locations

JP(24)