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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00975715
Other study ID # CTRI476B1301
Secondary ID
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


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
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