The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT00807989
First received: November 28, 2008
Last updated: June 29, 2015
Last verified: June 2015
Results First Received: January 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epilepsy
Interventions: Drug: Carbamazepine
Drug: Lamotrigine/Valproate

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Carbamazepine Carbamazepine 100mg/day for the first two weeks. At next two weeks, dose of Carbamazepine was increased to 200mg/day in two divided doses
Lamotrigine/Valproate

Lamotrigine and Valproate combination therapy

Lamotrigine 25mg/day for the first two weeks. At next two weeks, LTG 50 mg once a day


Participant Flow:   Overall Study
    Carbamazepine     Lamotrigine/Valproate  
STARTED     107     100  
COMPLETED     104     98  
NOT COMPLETED     3     2  



  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
Carbamazepine

Carbamazepine

Carbamazepine

Lamotrigine/Valproate

Lamotrigine and Valproate combination therapy

Lamotrigine/Valproate

Total Total of all reporting groups

Baseline Measures
    Carbamazepine     Lamotrigine/Valproate     Total  
Number of Participants  
[units: participants]
  104     98     202  
Age  
[units: Year]
Mean (Standard Deviation)
  33.2  (14.6)     36.5  (13.7)     34.8  (14.2)  
Gender  
[units: participants]
     
Female     51     48     99  
Male     53     50     103  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     104     98     202  



  Outcome Measures
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1.  Primary:   Retention Rate After 52 Weeks Maintenance Period   [ Time Frame: 52 weeks ]

2.  Secondary:   Seizure Free Rate for 24 Weeks at Initial Target Dose   [ Time Frame: 24 weeks ]

3.  Secondary:   Seizure Free Rate for 52 Weeks at Initial Target Dose   [ Time Frame: 52 weeks ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Yoon
Organization: Yonsei University Severance Hospital
phone: .
e-mail: BILEE@yuhs.ac


No publications provided


Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT00807989     History of Changes
Other Study ID Numbers: 109887
Study First Received: November 28, 2008
Results First Received: January 20, 2014
Last Updated: June 29, 2015
Health Authority: Korea: Institutional Review Board