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Trial record 45 of 76 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

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

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.
 
ClinicalTrials.gov Identifier: NCT00807989
Recruitment Status : Completed
First Posted : December 15, 2008
Results First Posted : May 29, 2015
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE November 28, 2008
First Posted Date  ICMJE December 15, 2008
Results First Submitted Date  ICMJE January 20, 2014
Results First Posted Date  ICMJE May 29, 2015
Last Update Posted Date July 27, 2015
Study Start Date  ICMJE March 2008
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2008)
Retention rate [ Time Frame: 52 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description An Open label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • Drug: Carbamazepine
  • Drug: Lamotrigine/Valproate
Study Arms  ICMJE
  • Active Comparator: Carbamazepine
    Carbamazepine
    Intervention: Drug: Carbamazepine
  • Experimental: Lamotrigine/Valproate
    Lamotrigine and Valproate combination therapy
    Intervention: Drug: Lamotrigine/Valproate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2015)
207
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2008)
220
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00807989
Other Study ID Numbers  ICMJE 109887
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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.
PRS Account Yonsei University
Verification Date June 2015

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