Clinical Trial: A Study of the Efficacy and Safety of Topiramate as an add-on Therapy in the Treatment of Epilepsy Patients With Lennox-Gastaut Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Blind Trial of Topiramate in Subjects With Lennox-Gastaut Syndrome.

Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of topiramate as add-on therapy in the treatment of epilepsy patients with Lennox-Gastaut syndrome, a severe form of epilepsy in which there are mixed types of seizures.

Detailed Summary: Lennox-Gastaut syndrome is a severe form of epilepsy that usually develops in children 4 years of age and younger. It is characterized by several seizure types and developmental delay. Tonic seizures, in which the muscle tone is greatly increased and body, arms and legs make sudden stiffening movements, is particularly common in Lennox-Gastaut syndrome. Although atonic seizures, in which there is a sudden loss of muscle tone and strength, can occur in individuals with this syndrome. Control of seizures is difficult because they are usually resistant to antiepileptic drugs. Topiramate is a drug that is currently widely used for the treatment of seizures in adults and pediatric patients (2 to 16 years of age). This is a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of topiramate as an add-on therapy in patients with Lennox-Gastaut syndrome. The study is composed of two phases: baseline (28 days) and double-blind treatment (approximately 11 weeks). Patients or their guardians/parents are given diaries to record information on seizures occurring during the study. During the baseline phase, the patient continues to receive the antiepileptic drug they have been taking. The double-blind phase is divided into two periods: titration, in which the topiramate dose was gradually increased (21 days) (patient's antiepileptic drug continues; this dose remains the same) and maintenance (56 days). The dose of both topiramate and the patient's antiepileptic drug remain constant during the maintenance period. Based on the investigator's judgment, all patients completing the double-blind period could be enrolled into an extension phase of the study. The primary assessment of effectiveness is the percent reduction from baseline in seizure rates (all types of seizures) in the double-blind phase. Safety assessments include the frequency of adverse events, results of clinical laboratory tests (hematology, biochemistry, and urinalysis
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Current Primary Outcome: Percent reduction from baseline in seizure rates (all types of seizures) in the double-blind phase. Percent reduction in drop attacks (tonic-clonic) and parent/guardian global evaluation at end of study

Original Primary Outcome: Same as current

Current Secondary Outcome: Percent treatment responders all types of seizures. Percent treatment responders drop attacks (tonic-clonic seizures). Safety evaluations conducted throughout the study.

Original Secondary Outcome: Same as current

Information By: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Dates:
Date Received: October 7, 2005
Date Started: August 1993
Date Completion:
Last Updated: June 2, 2011
Last Verified: January 2011