BACKGROUND: Patients with Lennox-Gastaut syndrome, a rare, severe double-blind, placebo-controlled trial done at 24 clinical sites in the. To confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with Lennox-Gastaut syndrome. Epilepsy Lennox-Gastaut Syndrome, Drug: GWPP 20 mg/kg/day Dose This study was a randomized, double-blind, week comparison of
syndrome Lennox-Gastaut Double-blind in trials
Eligibility For people ages Key Inclusion Criteria: Male or non-pregnant, non-lactating female, age 2 to 35 years, inclusive as of the day of the Screening Visit. Clinical diagnosis of Lennox-Gastaut syndrome, where seizures that result in drops are not completely controlled by current antiepileptic treatments. Onset of seizures at 11 years of age or younger.
Must be receiving at least 1 concomitant AED and up to 4 concomitant anti-epileptic treatments. Etiology of seizures is a degenerative neurological disease. History of hemiclonic seizures in the first year of life. Subject only has drop seizures in clusters, where individual seizures cannot be counted reliably. Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction or stroke.
Receiving concomitant therapy with: Currently receiving an investigational product. Maximum daily dose is Measure Percent reduction from baseline in seizure rates all types of seizures in the double-blind phase. Measure Percent treatment responders all types of seizures. Percent treatment responders drop attacks tonic-clonic seizures. Safety evaluations conducted throughout the study. A double-blind, randomized trial of topiramate in Lennox-Gastaut syndrome.
Topiramate YL Study Group. Conditions Conditions usually refer to a disease, disorder, syndrome, illness, or injury. Interventions Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer: In Phase 1 Phase I clinical trials, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase 2 Phase II clinical trials, the study drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
In Phase 3 Phase III clinical trials, the study drug or treatment is given to large groups of people 1,, to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. In Phase 4 Phase IV clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
Rare Diseases Alphabetic A-Z. Percent reduction from baseline in seizure rates all types of seizures in the double-blind phase.
A double-blind, randomized trial of topiramate in Lennox-Gastaut syndrome
Patients with Lennox-Gastaut syndrome, a rare, severe form of epileptic In this randomised, double-blind, placebo-controlled trial done at Design/Methods: Eligible patients were 2–55 years old and had a clinical . with Lennox-Gastaut Syndrome (LGS): Pooled Results from 2 Trials (S). Abstract. Objective: To evaluate the efficacy and safety of topiramate as adjunctive therapy for Lennox–Gastaut syndrome in a multicenter, double-blind.