Navigation Links
Data Show Rufinamide, an Investigational Adjunctive Treatment for Lennox- Gastaut Syndrome, Reduced Drop Attacks by More Than 40%
Date:5/20/2008

Placebo-Controlled Study Results Published in May 20 Issue of Neurology

WOODCLIFF LAKE, N.J., May 20 /PRNewswire/ -- Eisai Corporation of North America announced today the publication of a placebo-controlled study in Neurology that found patients with Lennox-Gastaut syndrome (LGS) treated with the investigational antiepileptic agent rufinamide as adjunctive therapy experienced more than 40% fewer drop attacks than patients who received placebo (increase of 1.4%). The differences between rufinamide and placebo were observed as early as week two of the study. LGS is a severe form of generalized epilepsy that develops in early childhood and is characterized by multiple types of treatment-resistant seizures and high rates of seizure-related injury.

"Lennox-Gastaut syndrome is a devastating form of pediatric epilepsy usually resulting in multiple seizures occurring several times a day and is often associated with impaired mental development," said the study's lead author Tracy Glauser, MD, Director, Comprehensive Epilepsy Program, Cincinnati Children's Hospital Medical Center, Ohio. "Existing antiepileptics offer limited seizure control and there may be difficulties with tolerability."

Study Methods

The study was a multicenter, double-blind, placebo-controlled, randomized, parallel-group study. Male and female patients (between 4 and 30 years of age) were included if they had a diagnosis of inadequately controlled seizures associated with LGS (including both atypical absence seizures and drop attacks) and were being treated with 1 to 3 concomitant stable dose antiepileptic drugs (AEDs). Each patient must have had at least 90 seizures in the 28-day baseline period prior to study entry. One hundred thirty-nine eligible patients were randomized; 138 patients received either rufinamide (titrated up to 45mg/kg per day) (n=74) or placebo (n=64) in addition to their other AEDs.

The median percentage reduction in total seizure frequency from baseline was greater in the rufinamide therapy group than in the placebo group (32.7% vs 11.7%) (p<0.002). The rufinamide-treated patients had 42.5% median percentage reduction in tonic-atonic seizure (drop attack) frequency per 28 days from baseline as compared with 1.4% increase in the placebo-treated patients (p<0.0001). The rufinamide group had a statistically significant improvement in seizure severity (p<0.005) and a higher percentage of patients who experienced at least a 50% reduction in tonic-atonic seizure frequency per 28 days compared with placebo (42.5% vs 16.7; p=0.002). The common adverse events reported by more than 10% of patients receiving rufinamide and at a higher frequency than in placebo-treated patients were somnolence (24.3% with rufinamide vs 12.5% with placebo) and vomiting (21.6% vs 6.3%).

About Rufinamide

Rufinamide is a structurally novel compound that acts as a broad-spectrum anticonvulsant originally discovered and developed by Novartis Pharma AG. The New Drug Application (NDA) is pending review for safety and efficacy with the U.S. Food and Drug Administration. Eisai acquired an exclusive worldwide license to develop, manufacture and market rufinamide for any human therapeutic use with the exception of bipolar mood disorder, anxiety disorders and ophthalmologic disorders from Novartis Pharma AG in 2004.

About LGS

It is estimated that the incidence of LGS ranges from 1,400 to 4,500 new cases each year in the United States. Symptoms of LGS include a variety of seizure types, with tonic-atonic seizures being the most common. Atonic seizures (rapid loss of muscle tone and consciousness), and tonic seizures (where muscles contract continuously typically producing a stiffening of the legs and arms) lead to the sudden falls seen in LGS patients known as 'drop attacks.' Absence seizures (staring spells) and myoclonic seizures (sudden muscle jerks) are also commonly observed. All children with LGS will experience varying degrees of developmental delay and behavioral problems.

About Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd. and supports the activities of its operating companies in North America. These operating companies include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; MGI PHARMA, INC., an R&D and commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three areas of therapeutic focus: neurology, gastrointestinal disorders and oncology/critical care. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. More than 50 percent of the group sales are derived from overseas business. For more information, please visit http://www.eisai.co.jp.


'/>"/>
SOURCE Eisai Corporation of North America
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
2. A Worldwide Phase III Clinical Trial Seeks U.S. Patients to Explore Investigational Drug Phenoxodiol
3. Ardea Biosciences, Inc. Announces Completion of Phase 1 Clinical Trials of Novel Investigational HIV Drug RDEA806
4. ECLIPSE Data on Effects of Otsukas Investigational Novel Treatment, Tolvaptan, on Advanced Heart Failure Patients Hemodynamics and Urine Output Featured in Heart Failure Society of Americas Late Breaking Trials
5. Replidynes Investigational Antibacterial Agent REP3123 Prevents Sporulation in Clostridium difficile
6. Replidynes Investigational Antibacterial Agent REP3123 Prevents Toxin Production in Clostridium difficile
7. Wyeth Presents Phase 3 Fracture Data for Bazedoxifene, an Investigational Therapy for Osteoporosis
8. Newly Published Phase II Study Shows the Investigational Drug Vandetanib Prolongs Progression-Free Survival in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
9. KineMed Presents Preclinical Data for Investigational Agent Demonstrating Neurogenesis and Confirming Improvements in Behavioral Model
10. Lexicon Reports Initial Clinical Trial Results for LX1031, an Investigational New Drug for Irritable Bowel Syndrome
11. Roches Investigational Polymerase Inhibitor, Combined with PEGASYS(R) and COPEGUS(TM), Shows Potent Antiviral Activity in Treatment of Chronic Hepatitis C at Four Weeks
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... FALLS, N.J., Dec. 8, 2016 CANTEL MEDICAL CORP. ... income of $18,800,000, or $0.45 per diluted share, on a ... first quarter ended October 31, 2016. This compares with net ... of $153,779,000 for the first quarter ended October 31, 2015. ... first quarter ended October 31, 2016 to $21,323,000, or $0.51 ...
(Date:12/8/2016)... , Dec. 8, 2016   Mederi Therapeutics Inc . has announced regulatory ... Therapy, a non-surgical treatment for chronic gastroesophageal reflux disease (GERD). ... ... and broadcast during the Chinese Congress of Digestive Endoscopy, by Professor Jun Liu, Director ... , , "We are very ...
(Date:12/8/2016)... BEIJING , and SAN DIEGO , ... genomic services and solutions with cutting edge next-generation sequencing and ... biotechnology company; and the Genome Institute of ... (NovogeneAIT) – a new joint venture between Novogene and AITbiotech ... at Biopolis, Singapore .   ...
Breaking Medicine Technology:
(Date:12/7/2016)... Orleans, LA (PRWEB) , ... December 07, 2016 ... ... technique used to treat wrinkles and deep lines by smoothing and tightening the ... minimally invasive techniques out there to address facial aging with very little downtime, ...
(Date:12/7/2016)... ... 2016 , ... It is vital for any lab to secure funding, and ... team at Beckman Coulter has designed Kaluza, templates with advanced analytical tools to streamline ... operate in a GLP (Good Laboratory Practice) fashion. , With features designed to simplify ...
(Date:12/7/2016)... ... ... to blow out his candles on his 14th birthday, Estefano Reano had only one wish: ... Joe DiMaggio Children’s Hospital surprised his family with a phone call that made his wish ... was playing at home, when we got the phone call telling us there was a ...
(Date:12/7/2016)... ... December 07, 2016 , ... One of two inventors from Glen Burnie, ... is painful for her. "This is why the co-inventor and I have designed a ... They then created a prototype of the patent-pending AV-AIR, a device that serves as ...
(Date:12/7/2016)... Honolulu, HI (PRWEB) , ... December 07, 2016 ... ... Dermatology is proud to announce that its fully redesigned website, which launched October ... well as a sleek responsive design and easy-to-navigate layout. Visitors and patients can ...
Breaking Medicine News(10 mins):