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Banzel (Rufinamide) - Summary

 
 



BANZEL SUMMARY

BANZEL™ (rufinamide) Tablets

BANZEL (rufinamide) is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs).

BANZEL (rufinamide) is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults.


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NEWS HIGHLIGHTS

Media Articles Related to Banzel (Rufinamide)

How stress increases seizures for patients with epilepsy
Source: Epilepsy News From Medical News Today [2016.06.15]
Epilepsy changes the way the brain responds to stress, researchers find, which may explain why stress can increase seizure frequency.

Childhood Vaccinations Rarely Spur Seizures, Study Finds
Source: MedicineNet Tetanus Specialty [2016.06.06]
Title: Childhood Vaccinations Rarely Spur Seizures, Study Finds
Category: Health News
Created: 6/6/2016 12:00:00 AM
Last Editorial Review: 6/6/2016 12:00:00 AM

Breast cancer drug found to reduce seizures
Source: Epilepsy News From Medical News Today [2016.05.13]
Findings from animal study could lead to improved seizure treatment in humans.

Algorithms that can predict epileptic seizures
Source: Epilepsy News From Medical News Today [2016.05.12]
Computer scientists and mathematicians at the CEU Cardenal Herrera University in Valencia have developed a prediction model that can warn epileptic sufferers of an upcoming seizure with 20 minutes...

Brain signals between seizures may explain memory problems in patients with epilepsy
Source: Epilepsy News From Medical News Today [2016.04.26]
Study suggests how future devices might prevent cognitive deficits. Between seizures and continually, brain cells in epileptic patients send signals that make "empty memories," perhaps explaining...

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Published Studies Related to Banzel (Rufinamide)

Efficacy of rufinamide in drug-resistant epilepsy: a meta-analysis. [2011.05]
Rufinamide is a new orally active antiepileptic drug that has been found to be effective in the treatment of partial seizures and drop attacks associated with Lennox-Gastaut syndrome. We performed a quantitative analysis of the efficacy of this new antiepileptic drug from all double-blind, add-on, randomized, placebo-controlled clinical trials published to date.

Rufinamide for the treatment of Lennox-Gastaut syndrome. [2011.04]
INTRODUCTION: Lennox-Gastaut syndrome (LGS) is a severe treatment-resistant childhood-onset epilepsy. This review examines the role of the new drug rufinamide for the treatment of LGS...

A randomized, double-blind, placebo-controlled, parallel-group study of rufinamide as adjunctive therapy for refractory partial-onset seizures. [2011.02]
PURPOSE: Efficacy and safety of adjunctive rufinamide (3,200 mg/day) was assessed in adolescents and adults with inadequately controlled partial-onset seizures receiving maintenance therapy with up to three antiepileptic drugs (AEDs)... CONCLUSIONS: Adjunctive treatment with rufinamide reduced total partial seizures in refractory patients. AEs reported were consistent with the known tolerability profile of rufinamide. Wiley Periodicals, Inc. (c) 2010 International League Against Epilepsy.

Bioavailability of three rufinamide oral suspensions compared with the marketed 400-mg tablet formulation: results from a randomized-sequence, open-label, four-period, four-sequence crossover study in healthy subjects. [2011.01]
BACKGROUND: Rufinamide is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients aged >/=4 years. OBJECTIVES: The primary purpose of this study was to compare the relative bioavailability and other pharmacokinetics of rufinamide administered as a 400-mg tablet formulation (reference) with 10 mL of a newly developed 40-mg/mL suspension (test) manufactured using 3 different homogenization speeds in healthy subjects under fed conditions. The study also explored whether homogenization speed had any effect on rufinamide pharmacokinetics when administered as a suspension formulation... CONCLUSION: This single-dose study in a small population of fed, healthy subjects found no statistically significant differences in relative bioavailability among each of the 3 test suspensions and the currently marketed 400-mg tablet formulation of rufinamide, meeting FDA and EMA regulatory requirements for assuming bioequivalence. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.

Update on rufinamide in childhood epilepsy. [2011]
Rufinamide is an orally active, structurally novel compound (1-[(2,6-difluorophenil1) methyl1]-1 hydro 1,2,3-triazole-4 carboxamide), which is structurally distinct from other anticonvulsant drugs. It was granted orphan drug status for the adjunctive treatment of Lennox-Gastaut syndrome (LGS) in the United States in 2004, and released for use in Europe in 2007.

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Clinical Trials Related to Banzel (Rufinamide)

Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome [Withdrawn]
The purpose of this study is to test if rufinamide has an effect on chronic neuropathic pain in patients with a post thoracotomy pain syndrome.

Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs [Active, not recruiting]

Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures [Completed]
The primary objective of this study is to evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult patients with refractory partial onset seizures currently inadequately treated with a maximum of three stable antiepileptic medications. Secondary objectives are to evaluate the effect of rufinamide on secondary and exploratory outcomes, to confirm the safety profile of rufinamide, and to assess the relationship between rufinamide plasma concentration and efficacy.

Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures [Completed]
This study is an open-label extension of Study E2080-A001-301. All patients will initiate the study at the total daily doses they were receiving at the end of the transition phase in E2080-A001-301 (2400 or 3200 mg/day) with an option, at the discretion of the Investigator, to incrementally increase doses to a maximum of 4800 mg/day. Safety variables and seizure frequency will be monitored throughout the study.

Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD) [Completed]
This is an eight week, randomized, double blind, placebo-controlled, exploratory study. Patients randomized to rufinamide (SYN111) will receive 250 mg BID (total daily dose 500mg) for one week then have their dose increased to 500 mg BID (total daily dose 1000mg) for the remaining 7 weeks of the study. If the 500 mg BID dose is not tolerated, one dose reduction is allowed.

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Reports of Suspected Banzel (Rufinamide) Side Effects

Vomiting (4)Pneumonia Aspiration (3)Dehydration (3)Aphasia (2)Sudden Unexplained Death in Epilepsy (2)Emotional Disorder (2)Crying (2)Blood Potassium Decreased (2)Confusional State (1)Excessive Eye Blinking (1)more >>


Page last updated: 2016-06-15

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