Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

TRI476

Placebo to TRI476

Benzodiazepines

About this trial

This is an interventional treatment trial for Partial Onset Seizures focused on measuring Seizures, oxcarbazepine, child

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TRI476

Placebo

Arm Description

Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.

Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.

Outcomes

Primary Outcome Measures

Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group

Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: "Percent change in partial onset seizure frequency per 28 days from the screening phase" = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 "Partial onset seizure frequency per 28 days" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28.

Secondary Outcome Measures

Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group

Partial onset seizure frequency per 28 days during a period between baseline and Week 4 was measured. Partial onset seizure frequency per 28 days (count/28 days)" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / Number of days during the phase x 28.

Percent of Participants With Response During Double-blind Phase, by Treatment Group

Responder rate was defined as the percent of participants with an at least 50% reduction in partial onset seizure frequency per 28 days from the screening phase.

Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type

Percent change in seizure frequency from baseline = 100 (T-B)/B, B=Seizure frequency per 28 days during baseline phase, T=Seizure frequency per 28 days during the double-blind phase. Seizure frequency per 28 days is calculated as: (seizure frequency during the double-blind phase / the number of days the seizure information were provided) x 28. Only patients with both baseline and corresponding post-baseline values are included.

Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group

Clinical Global Impression of Change (CGI) is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-C scores range from 1 (very much improved) through to 7 (very much worse).

Full Information

NCT ID

NCT00975715

First Posted

September 10, 2009

Last Updated

July 9, 2014

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00975715

Brief Title

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

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Partial Onset Seizures

Keywords

Seizures, oxcarbazepine, child

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TRI476

Arm Type

Experimental

Arm Description

Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.

Intervention Type

Drug

Intervention Name(s)

TRI476

Intervention Description

TRI476 oral suspension doses, based on body weight twice daily

Intervention Type

Drug

Intervention Name(s)

Placebo to TRI476

Intervention Description

Placebo oral suspension, taken twice daily

Intervention Type

Drug

Intervention Name(s)

Benzodiazepines

Intervention Description

Benzodiazepines could be used as needed as rescue medication during the duration of the study.

Primary Outcome Measure Information:

Title

Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group

Description

Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: "Percent change in partial onset seizure frequency per 28 days from the screening phase" = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 "Partial onset seizure frequency per 28 days" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28.

Time Frame

screening and 28 days

Secondary Outcome Measure Information:

Title

Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group

Description

Partial onset seizure frequency per 28 days during a period between baseline and Week 4 was measured. Partial onset seizure frequency per 28 days (count/28 days)" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / Number of days during the phase x 28.

Time Frame

baseline, 28 days and 56 days

Title

Percent of Participants With Response During Double-blind Phase, by Treatment Group

Description

Responder rate was defined as the percent of participants with an at least 50% reduction in partial onset seizure frequency per 28 days from the screening phase.

Time Frame

screening to 28 days

Title

Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type

Description

Percent change in seizure frequency from baseline = 100 (T-B)/B, B=Seizure frequency per 28 days during baseline phase, T=Seizure frequency per 28 days during the double-blind phase. Seizure frequency per 28 days is calculated as: (seizure frequency during the double-blind phase / the number of days the seizure information were provided) x 28. Only patients with both baseline and corresponding post-baseline values are included.

Time Frame

28 days

Title

Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group

Description

Clinical Global Impression of Change (CGI) is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-C scores range from 1 (very much improved) through to 7 (very much worse).

Time Frame

56 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

460-0004

Country

Japan

Facility Name

Novartis Investigative Site

City

Ohbu

State/Province

Aichi

ZIP/Postal Code

474-0031

Country

Japan

Facility Name

Novartis Investigative Site

City

Matsuyama

State/Province

Ehime

ZIP/Postal Code

790-8524

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka-city

State/Province

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

Novartis Investigative Site

City

Kameda-gun

State/Province

Hokkaido

ZIP/Postal Code

041-1111

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo-city

State/Province

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Novartis Investigative Site

City

Himeji

State/Province

Hyogo

ZIP/Postal Code

670-8540

Country

Japan

Facility Name

Novartis Investigative Site

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

658-0032

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

244-0842

Country

Japan

Facility Name

Novartis Investigative Site

City

Koshi-city

State/Province

Kumamoto

ZIP/Postal Code

861-1196

Country

Japan

Facility Name

Novartis Investigative Site

City

Kashiwazaki

State/Province

Niigata

ZIP/Postal Code

945-8585

Country

Japan

Facility Name

Novartis Investigative Site

City

Yufu

State/Province

Oita

ZIP/Postal Code

879-5593

Country

Japan

Facility Name

Novartis Investigative Site

City

Kurashiki

State/Province

Okayama

ZIP/Postal Code

710-8522

Country

Japan

Facility Name

Novartis Investigative Site

City

Okayama-city

State/Province

Okayama

ZIP/Postal Code

700-8558

Country

Japan

Facility Name

Novartis Investigative Site

City

Neyagawa

State/Province

Osaka

ZIP/Postal Code

572-0085

Country

Japan

Facility Name

Novartis Investigative Site

City

Higashimatsuyama-shi

State/Province

Saitama

ZIP/Postal Code

355-0008

Country

Japan

Facility Name

Novartis Investigative Site

City

Moriyama-shi

State/Province

Shiga

ZIP/Postal Code

524-0022

Country

Japan

Facility Name

Novartis Investigative Site

City

Shimotsuke-city

State/Province

Tochigi

ZIP/Postal Code

329-0498

Country

Japan

Facility Name

Novartis Investigative Site

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-city

State/Province

Yamanashi

ZIP/Postal Code

409-3898

Country

Japan

Facility Name

Novartis Investigative Site

City

Gifu

ZIP/Postal Code

502-8558

Country

Japan

Facility Name

Novartis Investigative Site

City

Niigata

ZIP/Postal Code

950-2085

Country

Japan

Facility Name

Novartis Investigative Site

City

Saitama

ZIP/Postal Code

339-8551

Country

Japan

Facility Name

Novartis Investigative Site

City

Shizuoka

ZIP/Postal Code

420-8688

Country

Japan

Facility Name

Novartis Investigative Site

City

Yamagata

ZIP/Postal Code

990-0876

Country

Japan

12. IPD Sharing Statement

Links:

URL

http://www.novartisclinicaltrials.com/webapp/etrials/home.do

Description

Click here for more information about this study:

Partial Onset Seizures

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial