Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00975715
First received: September 10, 2009
Last updated: July 31, 2012
Last verified: July 2012
History of Changes

September 10, 2009
July 31, 2012
September 2009
February 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00975715 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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: Oxcarbazepine
  • Drug: Placebo Comparator
  • Experimental: TRI476
    TRI476
    Intervention: Drug: Oxcarbazepine
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
Not Provided
February 2015   (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
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2012

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