Clinical trial NCT00807989: The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2008-12-15
Enrollment: 207
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Retention Rate After 52 Weeks Maintenance Period
timeFrame: 52 weeks
Secondary outcomes:
measure: Seizure Free Rate for 24 Weeks at Initial Target Dose
timeFrame: 24 weeks
measure: Seizure Free Rate for 52 Weeks at Initial Target Dose
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Medical Center
Study officials:
affiliation: Yonsei Univ.
name: Byung-In Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Yonsei Univ.
name: Kyoung Heo
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National Univ.
name: Sang-Kun Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Ulsan Univ.
name: Sang-Ahm Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Gacheon Univ.
name: Dong-Jin Shin
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym Univ.
name: Hong-Ki Song
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic Univ.
name: Young-In Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Youngnam Univ.
name: Se-Jin Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Donga Univ.
name: Sang-Ho Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Cheonnam Univ.
name: Myung-Gyu Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang Univ.
name: Yo-Sik Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongsan Hosp.
name: Sang-Do Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan-Bak Hosp.
name: Sung-Eun Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungbuk Univ.
name: Sung-Pa Park
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanrim Univ.
name: Joo-Yong Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Bundang Cha
name: Ok-Jun Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Bong-Sang Hosp.
name: Soon-Ki Noh
role: PRINCIPAL_INVESTIGATOR
affiliation: I-wha Univ.
name: Hyang-Woon Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungnam Univ.
name: Jae-Moon Kim
role: PRINCIPAL_INVESTIGATOR
References: