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

Partial Onset Seizures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975715
• Other study ID #: CTRI476B1301
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 10, 2009
• Last updated: July 9, 2014
• Start date: September 2009
• Est. completion date: October 2012

Study information

• Verified date: July 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationJapan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Partial Onset Seizures
• Seizures

Intervention

Drug:
• TRI476
TRI476 oral suspension doses, based on body weight twice daily
• Placebo to TRI476
Placebo oral suspension, taken twice daily
• Benzodiazepines
Benzodiazepines could be used as needed as rescue medication during the duration of the study.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chuo-city	Yamanashi
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Gifu
Japan	Novartis Investigative Site	Higashimatsuyama-shi	Saitama
Japan	Novartis Investigative Site	Himeji	Hyogo
Japan	Novartis Investigative Site	Kameda-gun	Hokkaido
Japan	Novartis Investigative Site	Kashiwazaki	Niigata
Japan	Novartis Investigative Site	Kobe	Hyogo
Japan	Novartis Investigative Site	Koshi-city	Kumamoto
Japan	Novartis Investigative Site	Kurashiki	Okayama
Japan	Novartis Investigative Site	Matsuyama	Ehime
Japan	Novartis Investigative Site	Moriyama-shi	Shiga
Japan	Novartis Investigative Site	Nagoya-shi	Aichi
Japan	Novartis Investigative Site	Neyagawa	Osaka
Japan	Novartis Investigative Site	Niigata
Japan	Novartis Investigative Site	Ohbu	Aichi
Japan	Novartis Investigative Site	Okayama-city	Okayama
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Shimotsuke-city	Tochigi
Japan	Novartis Investigative Site	Shizuoka
Japan	Novartis Investigative Site	Yamagata
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yufu	Oita

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	screening and 28 days	No
Secondary	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.	baseline, 28 days and 56 days	No
Secondary	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.	screening to 28 days	No
Secondary	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.	28 days	No
Secondary	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).	56 days	No