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: July 9, 2014
Last verified: July 2014
Results First Received: October 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Partial Onset Seizures
Interventions: Drug: TRI476
Drug: Placebo to TRI476
Drug: Benzodiazepines

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 99 patients were randomized, one patient who did not receive study drug was excluded. A total of 48 participants were randomized to TRI476 and 51 to placebo. 7 participants discontinued during the titration period and 3 discontinued during the maintenance period. A total of 89 participants completed the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants kept same dosage of their traditional antiepileptics prior to screening and throughout the study. They received TRI476 or placebo in a 1:1 ratio. TRI476 dose was increased gradually, based on body weight during the titration period (day 0- 14). The tolerated dose was given during the maintenance period (up to day 56).

Reporting Groups
  Description
TRI476 Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
Placebo Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.

Participant Flow for 2 periods

Period 1:   Titration Period
    TRI476     Placebo  
STARTED     48     51  
COMPLETED     41     51  
NOT COMPLETED     7     0  
Adverse Event                 6                 0  
Protocol Violation                 1                 0  

Period 2:   Maintenance Period
    TRI476     Placebo  
STARTED     41     51  
COMPLETED     39     50  
NOT COMPLETED     2     1  
Adverse Event                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
TRI476 Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
Placebo Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
Total Total of all reporting groups

Baseline Measures
    TRI476     Placebo     Total  
Number of Participants  
[units: participants]
  48     51     99  
Age  
[units: years]
Mean ± Standard Deviation
  9.8  ± 2.91     9.2  ± 2.83     9.5  ± 2.87  
Gender  
[units: participants]
     
Female     22     24     46  
Male     26     27     53  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group   [ Time Frame: baseline, 28 days and 56 days ]

3.  Secondary:   Percent of Participants With Response During Double-blind Phase, by Treatment Group   [ Time Frame: screening to 28 days ]

4.  Secondary:   Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type   [ Time Frame: 28 days ]

5.  Secondary:   Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group   [ Time Frame: 56 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis
phone: 41 61 324 1111


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: July 9, 2014
Health Authority: United States: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare