SAN DIEGO--(BUSINESS WIRE)--
Data from a long-term, open-label extension study (OLE) evaluating ONFI (clobazam) Tablets CIV for the adjunctive treatment of drop seizures associated with Lennox-Gastaut syndrome (LGS) were presented as a late-breaking poster at the annual meeting of the American Epilepsy Society (AES).1 A 1,5-benzodiazepine, ONFI was approved by the U.S. Food and Drug Administration (FDA) in 2011 for the adjunctive treatment of seizures associated with LGS in adults and children as young as two.2
This study enrolled patients with a current or previous diagnosis of LGS aged 2 to 60 years old. Patients had previously completed one of two double-blind clinical trials evaluating ONFI as adjunctive therapy for drop seizures associated with LGS, and qualifying patients were given the option of tapering off ONFI or continuing in the OLE. Of 306 patients previously enrolled in these two earlier studies, 267 entered the OLE during the enrollment period of Dec. 28, 2005 through Dec. 15, 2009. Approximately 70 percent (188 of 267) of these patients remained in the study until its conclusion on March 23, 2012.1
The primary efficacy endpoint of the study was median percentage decrease in average weekly rate of drop seizures measured at eight separate time points from month 3 through three years, compared with last assessment before first dose of ONFI. Results from this endpoint include 113 patients who received ONFI for three years.1 Further results for those patients who received ONFI for greater than three years are expected to be published during 2013.
While LGS represents a small percentage of patients an epilepsy specialist typically treats, the diagnosis often requires a significant amount of time, resources and attention because of the frequency and severity of seizures, said Yu-tze Ng, director of epilepsy at the University of Oklahoma College of Medicine and lead investigator of the study. Its important to collect long-term data because these challenging seizures associated with LGS typically continue throughout the patients life.
LGS is a rare and severe form of epilepsy that is typically diagnosed in childhood and often persists into adulthood.4,5,6 LGS is associated with multiple types of seizures with periods of frequent seizures, and daily seizures are common.7 Some of these seizures, including atonic, tonic and myoclonic seizures, may cause falls and are called drop seizures (also referred to as drop attacks), which may result in injury.8
There is no quick fix for LGS. The diagnosis takes patients, their families and health care teams on a long-term journey from childhood diagnosis into the adult years, from one seizure type to the next, while multiple AEDs are used to manage the condition, said Juliann Paolicchi, MD, director of the pediatric comprehensive epilepsy program at Weill Cornell Medical Collegein New York, as well as co-investigator of the study. We are pleased that Lundbeck was able to partner with a group of clinical researchers to investigate the use of ONFI for this difficult to treat disorder.
The most common adverse events experienced in this OLE (15%) included upper respiratory infection, pyrexia, somnolence, pneumonia, fall and otitis media. A total of 79 (29.6%) patients discontinued the study for the following reasons: patient/parent/caregiver request (33 patients), lack of efficacy (15), adverse events (10), death (9) and other reasons (12).1
About the Presentation
This study was presented at AES on Saturday, Dec. 1, 11:45 a.m. 1:45 p.m., during Poster Session 1 at the San Diego Convention Center in Hall B, Ground Level.