Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Adjunctive rufinamide reduces refractory partial-onset seizures

01.10.2010
More than 50 percent reduction in partial seizure frequency; safety, efficacy confirmed

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 healthnews@wiley.com

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!
Further information:
http://www.wiley.com

More articles from Studies and Analyses:

nachricht New study from the University of Halle: How climate change alters plant growth
12.01.2018 | Martin-Luther-Universität Halle-Wittenberg

nachricht Disarray in the brain
18.12.2017 | Universität zu Lübeck

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Artificial agent designs quantum experiments

On the way to an intelligent laboratory, physicists from Innsbruck and Vienna present an artificial agent that autonomously designs quantum experiments. In initial experiments, the system has independently (re)discovered experimental techniques that are nowadays standard in modern quantum optical laboratories. This shows how machines could play a more creative role in research in the future.

We carry smartphones in our pockets, the streets are dotted with semi-autonomous cars, but in the research laboratory experiments are still being designed by...

Im Focus: Scientists decipher key principle behind reaction of metalloenzymes

So-called pre-distorted states accelerate photochemical reactions too

What enables electrons to be transferred swiftly, for example during photosynthesis? An interdisciplinary team of researchers has worked out the details of how...

Im Focus: The first precise measurement of a single molecule's effective charge

For the first time, scientists have precisely measured the effective electrical charge of a single molecule in solution. This fundamental insight of an SNSF Professor could also pave the way for future medical diagnostics.

Electrical charge is one of the key properties that allows molecules to interact. Life itself depends on this phenomenon: many biological processes involve...

Im Focus: Paradigm shift in Paris: Encouraging an holistic view of laser machining

At the JEC World Composite Show in Paris in March 2018, the Fraunhofer Institute for Laser Technology ILT will be focusing on the latest trends and innovations in laser machining of composites. Among other things, researchers at the booth shared with the Aachen Center for Integrative Lightweight Production (AZL) will demonstrate how lasers can be used for joining, structuring, cutting and drilling composite materials.

No other industry has attracted as much public attention to composite materials as the automotive industry, which along with the aerospace industry is a driver...

Im Focus: Room-temperature multiferroic thin films and their properties

Scientists at Tokyo Institute of Technology (Tokyo Tech) and Tohoku University have developed high-quality GFO epitaxial films and systematically investigated their ferroelectric and ferromagnetic properties. They also demonstrated the room-temperature magnetocapacitance effects of these GFO thin films.

Multiferroic materials show magnetically driven ferroelectricity. They are attracting increasing attention because of their fascinating properties such as...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

10th International Symposium: “Advanced Battery Power – Kraftwerk Batterie” Münster, 10-11 April 2018

08.01.2018 | Event News

See, understand and experience the work of the future

11.12.2017 | Event News

Innovative strategies to tackle parasitic worms

08.12.2017 | Event News

 
Latest News

Let the good tubes roll

19.01.2018 | Materials Sciences

How cancer metastasis happens: Researchers reveal a key mechanism

19.01.2018 | Health and Medicine

Meteoritic stardust unlocks timing of supernova dust formation

19.01.2018 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>