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

This study is currently recruiting participants.

Verified by Yonsei University, November 2008

First Received: November 28, 2008 Last Updated: December 12, 2008 History of Changes

Sponsored by:	Yonsei University
Information provided by:	Yonsei University
ClinicalTrials.gov Identifier:	NCT00807989

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 IV

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Divalproex sodium Lamotrigine Valproic acid Carbamazepine Valproate Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

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 Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator CBZ monotherapy arm	Drug: carbamazepine carbamazepine monotheraphy
1: Experimental combination of LTG and VPA arm	Drug: lamotrigine+valproate low dose of lamotrigine and valproate

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:	Yonsei Medical Center ( Byung-In Lee )
Study ID Numbers:	109887
Study First Received:	November 28, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00807989 History of Changes
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Psychotropic Drugs
Calcium Channel Blockers
Central Nervous System Diseases
Central Nervous System Depressants
Cardiovascular Agents
Brain Diseases
Antimanic Agents

Valproic Acid
Calcium, Dietary
Carbamazepine
Analgesics, Non-Narcotic
Epilepsy
Lamotrigine
Peripheral Nervous System Agents
Analgesics
Anticonvulsants

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Calcium Channel Blockers
Brain Diseases
Valproic Acid
Membrane Transport Modulators
Sensory System Agents
Therapeutic Uses
Analgesics
Tranquilizing Agents
Nervous System Diseases
Central Nervous System Depressants

Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Carbamazepine
Epilepsy
Analgesics, Non-Narcotic
Lamotrigine
GABA Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 06, 2009