A Study of the Effectiveness and Safety of Topiramate in the Treatment of Children With Epilepsy
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy; Seizures; Epilepsies, Partial
Intervention: topiramate (Drug)
Phase: Phase 3
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The purpose of this study is to evaluate the safety and effectiveness of oral topiramate as
add-on therapy in children with uncontrolled partial onset seizures who are taking one or two
standard anti-epileptic drugs.
Official title: Topiramate (RWJ 17021-000) Clinical Trial In Children With Partial Onset Seizures
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percent reduction in the average monthly seizure rate from baseline to end of treatment
Secondary outcome: Percent of patients responding to treatment (>= 50% reduction in seizure rate from baseline to end of treatment); parent's or guardian's global assessments at beginning of treatment and end of study; incidence of adverse events throughout study
Epilepsy is characterized by seizures, which are abnormal electrical discharges in the brain
that temporarily disrupt normal brain function. Seizures are classified as "generalized,"
originating in both sides of the brain simultaneously, or "partial-onset," starting in one
area of the brain. Antiepilepsy medications, such as topiramate, are selected based on
seizure type. This is a double-blind, placebo-controlled study that includes a baseline phase
and a treatment phase. During the baseline phase (8 weeks duration), patients receive a
stable dose of one or two standard antiepileptic drugs (AEDs), and the parent or guardian
records the occurrences of seizure in a diary. Patients who continue to have seizures during
treatment with standard AEDs proceed into the double-blind treatment phase. Patients then
receive topiramate or placebo once daily at a dosage of 25 milligrams[mg] or 50 mg based on
body weight (to 6mg/kg per day), increasing gradually to twice daily dosing at a maximum of
125-400 mg (based on body weight) for 112 days (16 weeks total duration of the double-blind
phase), while continuing on their standard AED regimen. Assessments of effectiveness include
the percent reduction in the average monthly seizure rate, percent of patients responding to
treatment (having equal to or greater than 50% reduction in seizure rate), and the parent's
or guardian's global assessment of medication at end of study. Safety assessments include the
incidence of adverse events throughout the study, clinical laboratory tests (hematology,
chemistry, urinalysis), neurologic examinations, and vital sign measurements (blood pressure,
pulse, body weight) at specific intervals during the treatment phase. The study hypothesis is
that topiramate, taken as add-on therapy to treatment with AEDs, will significantly reduce
seizure frequency, compared with placebo, in children with refractory partial epilepsy: that
is, children who continue to have seizures despite treatment with first-line AEDs. In
addition, it is hypothesized that topiramate is well-tolerated.
Oral topiramate, daily for 112 days. Starting dose is 25 mg or 50mg, based on body weight.
Maximum doses based on patient weight: 125 mg/day (36-54 pounds[lb]); 175 mg/day (55-74 lb);
225 mg/day (75-94 lb); and 400 mg/day (95 or more pounds). Matching placebo was used to
Minimum age: 1 Year.
Maximum age: 16 Years.
- Patients must weigh at least 36 pounds (16 kilograms)
- Patients must have partial onset seizures (with or without secondarily generalized
seizures) being treated with at least one, but no more than two antiepileptic drugs
- Patients must have at least 6 partial onset seizures during the 8-week baseline phase,
with at least one seizure during each 4-week period
- An electroencephalogram (EEG) with features consistent with partial epilepsy performed
prior to study initiation or during the baseline phase
- Females who are pregnant, nursing, or those not using adequate birth control if
capable of having children
- Patients with a treatable cause of seizures (for example, infections)
- Patients with a progressive disorder of the nervous system
- Patients with a clinical diagnosis of Lennox-Gastaut syndrome
- Patients with a history of generalized status epilepticus (repeated or prolonged
seizures) while on appropriate anti-epileptic therapy
Locations and Contacts
A study of the effectiveness and safety of topiramate in the treatment of children with epilepsy
Starting date: March 1994
Ending date: October 2000
Last updated: May 11, 2007