The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy
Information source: Yonsei University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: lamotrigine+valproate (Drug); carbamazepine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Yonsei University Official(s) and/or principal investigator(s):
Byung-In Lee, Principal Investigator, Affiliation: Yonsei Univ.
Kyoung Heo, Principal Investigator, Affiliation: Yonsei Univ.
Sang-Kun Lee, Principal Investigator, Affiliation: Seoul National Univ.
Sang-Ahm Lee, Principal Investigator, Affiliation: Ulsan Univ.
Dong-Jin Shin, Principal Investigator, Affiliation: Gacheon Univ.
Hong-Ki Song, Principal Investigator, Affiliation: Hallym Univ.
Young-In Kim, Principal Investigator, Affiliation: Catholic Univ.
Se-Jin Lee, Principal Investigator, Affiliation: Youngnam Univ.
Sang-Ho Kim, Principal Investigator, Affiliation: Donga Univ.
Myung-Gyu Kim, Principal Investigator, Affiliation: Cheonnam Univ.
Yo-Sik Kim, Principal Investigator, Affiliation: Wonkwang Univ.
Sang-Do Lee, Principal Investigator, Affiliation: Dongsan Hosp.
Sung-Eun Kim, Principal Investigator, Affiliation: Pusan-Bak Hosp.
Sung-Pa Park, Principal Investigator, Affiliation: Kyungbuk Univ.
Joo-Yong Kim, Principal Investigator, Affiliation: Hanrim Univ.
Ok-Jun Kim, Principal Investigator, Affiliation: Bundang Cha
Soon-Ki Noh, Principal Investigator, Affiliation: Bong-Sang Hosp.
Hyang-Woon Lee, Principal Investigator, Affiliation: I-wha Univ.
Jae-Moon Kim, Principal Investigator, Affiliation: Chungnam Univ.
Overall contact:
Byung-In Lee, Phone: 82-2-2228-1600, Email: bilee@yumc.yonsei.ac.kr
Summary
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.
Clinical Details
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)
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Retention rate
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Byung-In Lee, Phone: 82-2-2228-1600, Email: bilee@yumc.yonsei.ac.kr
Yonsei Medical Center, Seoul 120-752, Korea, Republic of; Recruiting
Byung-In Lee, Email: bilee@yumc.yonsei.ac.kr
Additional Information
Starting date: April 2008
Last updated: December 12, 2008
|
