Researchers from the Arkansas Epilepsy Program found treatment with rufinamide results in a significant reduction in seizure frequency compared with placebo, for patients with uncontrolled partial-onset seizures (POS). Details of this study are now available online in Epilepsia, a journal published by Wiley-Blackwell on behalf of the International League Against Epilepsy.
Epilepsy affects up to 2% of the worldwide population according to the Centers for Disease Control and Prevention. More than half of these patients experience POS, or focal seizures, which are initiated in one part of the brain. Despite an expanding number of antiepileptic drugs (AEDs) available to treat partial-onset epilepsy, about one-third of epilepsy patients remain resistant to available treatments and many more experience intolerable side effects, driving the search for therapeutic alternatives. The current study evaluated rufinamide, an AED with a novel triazole-derivative structure, to confirm its efficacy and safety at a dose of 1,600 mg twice daily as adjunctive treatment for refractory POS.
Eligible patients were male or female, aged 12-80 years, with POS with or without secondarily generalized seizures. Patients' seizures were inadequately controlled on stable doses of up to three concomitantly administered AEDs, with no evidence of AED treatment noncompliance. All medication taken regularly by patients, including AEDs, remained unchanged for at least 1 month prior to study start and throughout the study. Patients were enrolled at 61 centers in the U.S. and at four centers in Canada between February 2006 and March 2009. In total, 357 patients were randomly assigned to receive rufinamide (n = 176) or placebo (n = 181) and entered the titration phase, and 139 and 156 patients, respectively, completed the study. This study comprised a 56-day baseline phase (BP), 12-day titration phase, and 84-day maintenance phase (MP).
The researchers found that treatment with rufinamide resulted in a statistically significant reduction in total partial seizure frequency compared with placebo. Results also showed a 50% reduction in responder rate and total partial seizure frequency rate in patients treated with rufinamide. Several exploratory efficacy variables, including at least 75% responder rate and increase in the number of seizure-free days, were also associated with notably better results for rufinamide.
With respect to efficacy by seizure type, rufinamide was significantly superior to placebo for complex partial seizures, the most common seizure type, and numerically superior to placebo for simple partial seizures and secondarily generalized partial seizures. The median reduction in secondarily generalized partial seizures of 40% in this study is consistent with that previously observed at identical rufinamide dosage.
Study leader Victor Biton, M.D., comments, "Overall, there were no significant pharmacokinetic (PK) effects on either rufinamide or any second-generation AED when given with other medications." The research team confirmed PK results found in previous studies—showing lower oral bioavailability of rufinamide at higher doses, increased clearance of rufinamide with increasing body weight, and no effect of prolonged rufinamide dosing on the PK of rufinamide."
"Our study demonstrates that rufinamide is effective as adjunctive therapy in reducing total partial seizure frequency in treatment-refractory adolescent and adult patients, and confirms the known safety and tolerability profile of rufinamide in this patient population," concludes Dr. Biton.
This study is published in Epilepsia. Media wishing to receive a PDF of this article may contact firstname.lastname@example.org
Full citation: "A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Rufinamide as Adjunctive Therapy for Refractory Partial-onset Seizures." Victor Biton, Gregory Krauss, Blanca Vasquez-Santana, Francesco Bibbiani, Allison Mann, Carlos Perdomo, and Milind Narurkar. Epilepsia; Published Online: October 1, 2010 (DOI: 10.1111/j.1528-1167.2009.02729.x).
Epilepsia is the leading, most authoritative source for current clinical and research results on all aspects of epilepsy. As the journal of the International League Against Epilepsy, subscribers every month will review scientific evidence and clinical methodology in: clinical neurology, neurophysiology, molecular biology, neuroimaging, neurochemistry, neurosurgery, pharmacology, neuroepidemiology, and therapeutic trials. For more information, please visit http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1528-1167.
Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world's leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit www.wileyblackwell.com or our new online platform, Wiley Online Library (wileyonlinelibrary.com), one of the world's most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.
Dawn Peters | EurekAlert!
The Great Unknown: Risk-Taking Behavior in Adolescents
19.01.2017 | Max-Planck-Institut für Bildungsforschung
A sudden drop in outdoor temperature increases the risk of respiratory infections
11.01.2017 | University of Gothenburg
An important step towards a completely new experimental access to quantum physics has been made at University of Konstanz. The team of scientists headed by...
Yersiniae cause severe intestinal infections. Studies using Yersinia pseudotuberculosis as a model organism aim to elucidate the infection mechanisms of these...
Researchers from the University of Hamburg in Germany, in collaboration with colleagues from the University of Aarhus in Denmark, have synthesized a new superconducting material by growing a few layers of an antiferromagnetic transition-metal chalcogenide on a bismuth-based topological insulator, both being non-superconducting materials.
While superconductivity and magnetism are generally believed to be mutually exclusive, surprisingly, in this new material, superconducting correlations...
Laser-driving of semimetals allows creating novel quasiparticle states within condensed matter systems and switching between different states on ultrafast time scales
Studying properties of fundamental particles in condensed matter systems is a promising approach to quantum field theory. Quasiparticles offer the opportunity...
Among the general public, solar thermal energy is currently associated with dark blue, rectangular collectors on building roofs. Technologies are needed for aesthetically high quality architecture which offer the architect more room for manoeuvre when it comes to low- and plus-energy buildings. With the “ArKol” project, researchers at Fraunhofer ISE together with partners are currently developing two façade collectors for solar thermal energy generation, which permit a high degree of design flexibility: a strip collector for opaque façade sections and a solar thermal blind for transparent sections. The current state of the two developments will be presented at the BAU 2017 trade fair.
As part of the “ArKol – development of architecturally highly integrated façade collectors with heat pipes” project, Fraunhofer ISE together with its partners...
19.01.2017 | Event News
10.01.2017 | Event News
09.01.2017 | Event News
20.01.2017 | Awards Funding
20.01.2017 | Materials Sciences
20.01.2017 | Life Sciences