Pediatric drug-resistant epilepsy
Conditions
Interventions
(Titration Phase) Start sodium valproate at 15 mg/kg/day (up to 400 mg/day) 1-3 times daily, increasing to 25 mg/kg/day (up to 600 mg/day) 1-3 times daily after 1 week. After 3 weeks of sodium valproa
Sponsors
Enokizono Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Boys 4-15 years old, girls 4-9 years old (2) Patients with epilepsy who have one or more of the following types of seizures: focal onset seizures, focal bilateral tonic-clonic seizures (secondary generalization), generalized onset motor seizures, or unexplained onset motor seizures (3) Patients who have failed to achieve seizure resolution with any two antiepileptic drugs except sodium valproate and lamotrigine (4) Head MRI or CT, EEG, or blood tests within 2 year prior to enrollment (5) Patients who have obtained written consent from a parent or guardian or a surrogate
Exclusion criteria
Exclusion criteria: (1) Metabolic or neurodegenerative disease is suspected (2) Patients with hepatic dysfunction of moderate severity or greater (AST or ALT greater than 2.5 times the upper reference limit or total bilirubin greater than 1.5 times the upper reference limit) (3) Patients with absence seizures, atypical absence seizures, or nonconvulsive status epilepticus (4) Poor adherence to medication (generally assumed to take less than 70% of doses) (5) Inability of the patient or family members to keep an epilepsy medication log (6) Patients with a history of treatment with sodium valproate and lamotrigine combination therapy or monotherapy with either (7) Patients who are deemed inappropriate as research subjects by the investigator or others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of seizures-free patients in the maintenance phase (52 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Percentage of seizure-free patients during the incremental phase (10 weeks) and the maintenance phase (52 weeks), for a total of 62 weeks. (2) Percentage of patients who remained on the drug during the titration phase (10 weeks) and the maintenance phase (52 weeks), for a total of 62 weeks (3) Comparison of efficacy by seizure type, epilepsy type, and epilepsy syndrome (4) Changes in scalp EEG (30 minutes), number of abnormal epileptic waves, and background activity (5) Side effects and safety evaluation (6) Quality of life assessment using PedsQL | — |
Contacts
Public ContactTakashi Enokizono
University of Tsukuba Hospital
Outcome results
None listed