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

November 28, 2008
June 29, 2015
March 2008
May 2012   (final data collection date for primary outcome measure)
Retention Rate After 52 Weeks Maintenance Period [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
* 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Seizure Free Rate for 52 Weeks at Initial Target Dose [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00807989
109887
No
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