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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00975715
First received: September 10, 2009
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Partial Onset Seizures
Drug: TRI476
Drug: Placebo to TRI476
Drug: Benzodiazepines
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group [ Time Frame: screening and 28 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 28 days and 56 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: screening to 28 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: 56 days ] [ Designated as safety issue: No ]

    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).

    At each visit, the investigator assessed the patient for global symptoms in comparison with conditions at Day 0 in accordance with the following categorization: Marked improvement, moderate improvement, slight improvement, no change, slight aggravation, moderate aggravation, marked aggravation, not assessable.



Enrollment: 99
Study Start Date: September 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRI476
Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antipiletics dosage.
Drug: TRI476
TRI476 oral suspension doses, based on body weight twice daily
Drug: Benzodiazepines
Benzodiazepines could be used as needed as rescue medication during the duration of the study.
Placebo Comparator: Placebo
Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antipiletics dosage.
Drug: Placebo to TRI476
Placebo oral suspension, taken twice daily
Drug: Benzodiazepines
Benzodiazepines could be used as needed as rescue medication during the duration of the study.

  Eligibility

Ages Eligible for Study:   4 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975715

Locations
Japan
Novartis Investigative Site
Nagoya-shi, Aichi, Japan, 460-0004
Novartis Investigative Site
Ohbu, Aichi, Japan, 474-0031
Novartis Investigative Site
Matsuyama, Ehime, Japan, 790-8524
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan, 814-0180
Novartis Investigative Site
Kameda-gun, Hokkaido, Japan, 041-1111
Novartis Investigative Site
Sapporo-city, Hokkaido, Japan, 060-8648
Novartis Investigative Site
Himeji, Hyogo, Japan, 670-8540
Novartis Investigative Site
Kobe, Hyogo, Japan, 658-0032
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 244-0842
Novartis Investigative Site
Koshi-city, Kumamoto, Japan, 861-1196
Novartis Investigative Site
Kashiwazaki, Niigata, Japan, 945-8585
Novartis Investigative Site
Yufu, Oita, Japan, 879-5593
Novartis Investigative Site
Kurashiki, Okayama, Japan, 710-8522
Novartis Investigative Site
Okayama-city, Okayama, Japan, 700-8558
Novartis Investigative Site
Neyagawa, Osaka, Japan, 572-0085
Novartis Investigative Site
Higashimatsuyama-shi, Saitama, Japan, 355-0008
Novartis Investigative Site
Moriyama-shi, Shiga, Japan, 524-0022
Novartis Investigative Site
Shimotsuke-city, Tochigi, Japan, 329-0498
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8431
Novartis Investigative Site
Chuo-city, Yamanashi, Japan, 409-3898
Novartis Investigative Site
Gifu, Japan, 502-8558
Novartis Investigative Site
Niigata, Japan, 950-2085
Novartis Investigative Site
Saitama, Japan, 339-8551
Novartis Investigative Site
Shizuoka, Japan, 420-8688
Novartis Investigative Site
Yamagata, Japan, 990-0876
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00975715     History of Changes
Other Study ID Numbers: CTRI476B1301
Study First Received: September 10, 2009
Results First Received: October 8, 2013
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Seizures
oxcarbazepine
child

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Oxcarbazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014