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

This study has been completed.
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: November 28, 2008
Last updated: May 11, 2015
Last verified: May 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
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 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




Lamotrigine and Valproate combination therapy


Total Total of all reporting groups

Baseline Measures
    Carbamazepine     Lamotrigine/Valproate     Total  
Number of Participants  
[units: participants]
  104     98     202  
[units: Year]
Mean (Standard Deviation)
  33.2  (14.6)     36.5  (13.7)     34.8  (14.2)  
[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 ]

  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 NOT 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.

Results Point of Contact:  
Name/Title: Dr. Yoon
Organization: Yonsei University Severance Hospital
phone: .

No publications provided

Responsible Party: Yonsei University Identifier: NCT00807989     History of Changes
Other Study ID Numbers: 109887
Study First Received: November 28, 2008
Results First Received: January 20, 2014
Last Updated: May 11, 2015
Health Authority: Korea: Institutional Review Board