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
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: Carbamazepine
Drug: Lamotrigine/Valproate
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:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 207
Study Start Date: March 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Carbamazepine
Carbamazepine
Drug: Carbamazepine
Experimental: Lamotrigine/Valproate
Lamotrigine and Valproate combination therapy
Drug: Lamotrigine/Valproate

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
Yonsei Medical Center
Seoul, Korea, Republic of, 120-752
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 University
ClinicalTrials.gov Identifier: NCT00807989     History of Changes
Other Study ID Numbers: 109887
Study First Received: November 28, 2008
Results First Received: January 20, 2014
Last Updated: June 29, 2015
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 30, 2015