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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00807989
First Posted: December 15, 2008
Last Update Posted: July 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
November 28, 2008
December 15, 2008
January 20, 2014
May 29, 2015
July 27, 2015
March 2008
May 2012   (Final data collection date for primary outcome measure)
Retention Rate After 52 Weeks Maintenance Period [ Time Frame: 52 weeks ]
* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.
Retention rate [ Time Frame: 52 weeks ]
Complete list of historical versions of study NCT00807989 on ClinicalTrials.gov Archive Site
  • Seizure Free Rate for 24 Weeks at Initial Target Dose [ Time Frame: 24 weeks ]
  • Seizure Free Rate for 52 Weeks at Initial Target Dose [ Time Frame: 52 weeks ]
Not Provided
Not Provided
Not Provided
 
The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy
An Open Label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies (Phase Ⅳ)
To evaluate the efficacy of usual monotherapy and low dose combination of Lamotrigine and Valproate. Low dose combination may be more effective and tolerable because they are low dose and VPA reduce Lamotrigine metabolism.
An Open label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Epilepsy
  • Drug: Carbamazepine
  • Drug: Lamotrigine/Valproate
  • Active Comparator: Carbamazepine
    Carbamazepine
    Intervention: Drug: Carbamazepine
  • Experimental: Lamotrigine/Valproate
    Lamotrigine and Valproate combination therapy
    Intervention: Drug: Lamotrigine/Valproate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
May 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥16yr old
  • Who are diagnosed as epilepsy definitely
  • Who have minimum 2 unprovoked seizures and minimum 1 seizure in previous 3 months
  • Who need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2weeks)
  • Who is not pregnant
  • Who can report seizure diary by him/herself or caregiver
  • Who agree to this trial and provide informed consent.
  • Type of seizures : of generalized tonic-clonic, complex partial, and/or simple partial motor seizures;

Exclusion Criteria:

  • Who has progressive CNS disease.
  • Has serious systemic or psychiatric disease
  • Who is not suitable by investigator(uncooperative)
  • Who can not fill up diary check card
  • Is pregnant, breastfeeding, or planning to become pregnant
  • Exclusion - absence s. juvenile myoclonic epilepsy, atonic seizure, alcohol or other substance abusers, mental retardation etc.
  • Who cancels to agree to this trial and provide informed consent.
  • ALT, AST, bilirubin and BUN/Cr levels are more than twice normal range of them
  • WBC value is 2000 and less, Hb value is 9.0 and less, platelet count is 100,000 and less in CBC
  • Who took investigation products before participating this study
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00807989
109887
No
Not Provided
Not Provided
Yonsei University
Yonsei University
Not Provided
Principal Investigator: Byung-In Lee Yonsei Univ.
Principal Investigator: Kyoung Heo Yonsei Univ.
Principal Investigator: Sang-Kun Lee Seoul National Univ.
Principal Investigator: Sang-Ahm Lee Ulsan Univ.
Principal Investigator: Dong-Jin Shin Gacheon Univ.
Principal Investigator: Hong-Ki Song Hallym Univ.
Principal Investigator: Young-In Kim Catholic Univ.
Principal Investigator: Se-Jin Lee Youngnam Univ.
Principal Investigator: Sang-Ho Kim Donga Univ.
Principal Investigator: Myung-Gyu Kim Cheonnam Univ.
Principal Investigator: Yo-Sik Kim Wonkwang Univ.
Principal Investigator: Sang-Do Lee Dongsan Hosp.
Principal Investigator: Sung-Eun Kim Pusan-Bak Hosp.
Principal Investigator: Sung-Pa Park Kyungbuk Univ.
Principal Investigator: Joo-Yong Kim Hanrim Univ.
Principal Investigator: Ok-Jun Kim Bundang Cha
Principal Investigator: Soon-Ki Noh Bong-Sang Hosp.
Principal Investigator: Hyang-Woon Lee I-wha Univ.
Principal Investigator: Jae-Moon Kim Chungnam Univ.
Yonsei University
June 2015

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