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

September 10, 2009
February 19, 2014
September 2009
October 2012   (final data collection date for primary outcome measure)
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.
Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00975715 on ClinicalTrials.gov Archive Site
  • 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.

  • Seizure Frequency of specific duration [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Responder rate: defined as the proportion of patients with an at least 50% reduction in the partial epileptic seizure frequency. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Percent changes in the seizure frequency by subtype [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Clinical Global Impression of Change (CGIC) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Safety and tolerability(Adverse events, Laboratory tests, Vital signs, Electrocardiogram (ECG) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Partial Onset Seizures
  • Drug: TRI476
    TRI476 oral suspension doses, based on body weight twice daily
  • 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.
  • Experimental: TRI476
    Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antipiletics dosage.
    Interventions:
    • Drug: TRI476
    • Drug: Benzodiazepines
  • Placebo Comparator: Placebo
    Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antipiletics dosage.
    Interventions:
    • Drug: Placebo to TRI476
    • Drug: Benzodiazepines
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
October 2012
October 2012   (final data collection date for primary outcome measure)

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

Both
4 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00975715
CTRI476B1301
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP