Epilepsy
Conditions
Keywords
epilepsy, monotherapy conversion
Brief summary
This study includes patients 16 years of age or older with a confident diagnosis of epilepsy who are currently treated with an antiepileptic drug (AED) monotherapy but require a change in therapy due to inadequate seizure control and/or unacceptable side effects.
Interventions
DRUGlamotrigine
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 16 years old or older. * Have confident diagnosis of epilepsy. * Have been on the medication valproate for at least 3 months and is currently on a stable daily dose. * Male or female; females of child-bearing potential must have negative pregnancy test at screen and must agree to use an acceptable birth control method.
Exclusion criteria
* A history of hypersensitivity to the drug being studied. * Currently being treated with or has been treated in the past with the drug being studied. * Undergoing polytherapy treatment with the medication valproate and one or more other antiepileptic drug(s). * If undergoing treatment with vagal nerve stimulation, has had device implanted more than 30 days prior to enrollment. * Has taken an investigational drug or the medication Felbatol within the previous 30 days. * Is abusing alcohol and/or other substances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug levels of lamotrigine. | — |
Secondary
| Measure | Time frame |
|---|---|
| This study has no secondary outcome measures. | — |
Outcome results
None listed