Epilepsy
Conditions
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
Interventions
DRUGCarbamazepine
DRUGLamotrigine/Valproate
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate After 52 Weeks Maintenance Period | 52 weeks | \* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned. |
Secondary
| Measure | 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 |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carbamazepine Carbamazepine
Carbamazepine | 104 |
| Lamotrigine/Valproate Lamotrigine and Valproate combination therapy
Lamotrigine/Valproate | 98 |
| Total | 202 |
Baseline characteristics
| Characteristic | Carbamazepine | Lamotrigine/Valproate | Total |
|---|---|---|---|
| Age, Continuous | 33.2 Year STANDARD_DEVIATION 14.6 | 36.5 Year STANDARD_DEVIATION 13.7 | 34.8 Year STANDARD_DEVIATION 14.2 |
| Region of Enrollment Korea, Republic of | 104 participants | 98 participants | 202 participants |
| Sex: Female, Male Female | 51 Participants | 48 Participants | 99 Participants |
| Sex: Female, Male Male | 53 Participants | 50 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 60 / 104 | 59 / 98 |
| serious Total, serious adverse events | 9 / 104 | 0 / 98 |
Outcome results
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.
Time frame: 52 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carbamazepine | Retention Rate After 52 Weeks Maintenance Period | 104 participants |
| Lamotrigine/Valproate | Retention Rate After 52 Weeks Maintenance Period | 98 participants |
Secondary
Seizure Free Rate for 24 Weeks at Initial Target Dose
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carbamazepine | Seizure Free Rate for 24 Weeks at Initial Target Dose | 51 participants |
| Lamotrigine/Valproate | Seizure Free Rate for 24 Weeks at Initial Target Dose | 59 participants |
Secondary
Seizure Free Rate for 52 Weeks at Initial Target Dose
Time frame: 52 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carbamazepine | Seizure Free Rate for 52 Weeks at Initial Target Dose | 43 participants |
| Lamotrigine/Valproate | Seizure Free Rate for 52 Weeks at Initial Target Dose | 50 participants |