A Study of the Effectiveness and Safety of Topiramate in the Treatment of Children With Epilepsy

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236743
First received: October 7, 2005
Last updated: June 6, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Epilepsy
Epilepsies, Partial
Seizures
Drug: topiramate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Topiramate (RWJ 17021-000) Clinical Trial In Children With Partial Onset Seizures

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Percent reduction in the average monthly seizure rate from baseline to end of treatment

Secondary Outcome Measures:
  • 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

Enrollment: 90
Study Start Date: June 1994
Study Completion Date: October 2000
Detailed Description:

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 maintain blinding.

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 (AEDs)
  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236743

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00236743     History of Changes
Other Study ID Numbers: CR005467
Study First Received: October 7, 2005
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
topiramate
epilepsy
partial epilepsies
partial epilepsy
seizures
epileptic seizures
partial seizure disorder
children
pediatric

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on August 20, 2014