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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00807989
First received: November 28, 2008
Last updated: June 25, 2010
Last verified: November 2008
History of Changes
  Purpose

This study will determine the differences of efficacy and safety between the LTG/VPA polytherapy and CBZ monotherapy as a first line regimen in generalized tonic-clonic, complex partial, and/or simple partial seizures.


Condition Intervention Phase
Epilepsy
 Drug: lamotrigine+valproate
Drug: carbamazepine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Retention rate [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: April 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
CBZ monotherapy arm
 Drug: carbamazepine
carbamazepine monotheraphy
Other Name: tegretolCR
Experimental: 1
combination of LTG and VPA arm
 Drug: lamotrigine+valproate
low dose of lamotrigine and valproate
Other Name: lamictal and dapakine crono

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807989

Contacts
Contact: Byung-In Lee 82-2-2228-1600 bilee@yumc.yonsei.ac.kr

Locations
Korea, Republic of
Yonsei Medical Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Byung-In Lee         bilee@yumc.yonsei.ac.kr    
Sponsors and Collaborators
Yonsei University
Investigators
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.
  More Information

No publications provided

Responsible Party: Byung-In Lee, Yonsei Medical Center
ClinicalTrials.gov Identifier: NCT00807989     History of Changes
Other Study ID Numbers: 109887
Study First Received: November 28, 2008
Last Updated: June 25, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lamotrigine
Valproic Acid
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
 Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013