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Sponsored by: |
Yonsei University |
---|---|
Information provided by: | Yonsei University |
ClinicalTrials.gov Identifier: | NCT00807989 |
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 |
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) |
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
|
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Byung-In Lee | 82-2-2228-1600 | bilee@yumc.yonsei.ac.kr |
Korea, Republic of | |
Yonsei Medical Center | Recruiting |
Seoul, Korea, Republic of, 120-752 | |
Contact: Byung-In Lee bilee@yumc.yonsei.ac.kr |
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. |
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 |
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 |
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 |