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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.
An Open label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbamazepine | Active Comparator | Carbamazepine |
|
| Lamotrigine/Valproate | Experimental | Lamotrigine and Valproate combination therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbamazepine | Drug |
| ||
| Lamotrigine/Valproate |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Rate After 52 Weeks Maintenance Period | * Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure Free Rate for 24 Weeks at Initial Target Dose | 24 weeks | |
| Seizure Free Rate for 52 Weeks at Initial Target Dose | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Medical Center | Seoul | 120-752 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carbamazepine | Carbamazepine 100mg/day for the first two weeks. At next two weeks, dose of Carbamazepine was increased to 200mg/day in two divided doses |
| FG001 | Lamotrigine/Valproate | Lamotrigine and Valproate combination therapy Lamotrigine 25mg/day for the first two weeks. At next two weeks, LTG 50 mg once a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carbamazepine | Carbamazepine Carbamazepine |
| BG001 | Lamotrigine/Valproate | Lamotrigine and Valproate combination therapy Lamotrigine/Valproate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention Rate After 52 Weeks Maintenance Period | * Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned. | Posted | Number | participants | 52 weeks |
|
|
52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carbamazepine | Carbamazepine Carbamazepine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meningoencephalitis herpetic | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yoon | Yonsei University Severance Hospital | BILEE@yuhs.ac |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D000077213 | Lamotrigine |
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 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. | Principal Investigator |
| BG002 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Seizure Free Rate for 24 Weeks at Initial Target Dose | Posted | Number | participants | 24 weeks |
|
|
|
| Secondary | Seizure Free Rate for 52 Weeks at Initial Target Dose | Posted | Number | participants | 52 weeks |
|
|
|
| 9 |
| 104 |
| 60 |
| 104 |
| EG001 | Lamotrigine/Valproate | Lamotrigine and Valproate combination therapy Lamotrigine/Valproate | 0 | 98 | 59 | 98 |
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Alcoholic seizure | Nervous system disorders | Systematic Assessment |
|
| Atonic seizures | Nervous system disorders | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Facet joint syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | Systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Weight gain | Metabolism and nutrition disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
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| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |