Preliminary results from a new Phase III pediatrics study, announced by Eisai,
demonstrate that the anti-epilepsy treatment Zonegran(R) (zonisamide/ZNS) is
more effective than placebo and well tolerated in pediatric patients with
partial-onset seizures treated with one or two other anti-epileptic drugs.
The CATZ study, a double blind, randomized, multi-center,
placebo-controlled study, was conducted to examine the efficiency and
safety/tolerability of adjunctive zonisamide. The study was carried out on 207
pediatric patients between the ages of 6 to 17 years with partial-onset seizures
who were taking one or two anti-epileptic drugs.
The study’s primary
endpoint was the proportion of responders measured as ‘greater than or equal to’
50% seizure frequency reduction after a treatment period of 12 weeks. The
safety/tolerability evaluation included assessing any treatment-emergent adverse
events (TEAEs).
The results of this study were presented for the first
time at the 29th International Epilepsy Congress in Rome. (28 Aug. until 1 Sept.
2011).
Professor Renzo Guerrini of the Children’s Hospital Anna Meyer,
at University of Florence in Italy commented on the study saying:
“There are a large proportion of children who do not get complete
seizure control and have to take more than one type of anti-epileptic to reduce
seizures. We know that zonisamide is already a successful add-on treatment and
is also very effective in newly diagnosed adults with epilepsy. I welcome these study results as they
indicate that the pediatric population could stand to significantly benefit
too.”
The study, divided into two groups, with 86.9 % of
patients assigned to the zonisamide group and 90 % of patients in the placebo
group, revealed that significantly more patients responded positively to
treatment with zonisamide (50.5%) compared with those in the placebo group
(31.0%).
Safety and tolerability evaluations demonstrated a similar
overall incidence of TEAEs in the zonisamide group (55.1%) versus placebo
(50.0%). Both groups displayed low rates of serious TEAEs (Zonisamide 3.7% vs.
Placebo 2.0%), and TEAEs causing withdrawal from the study (0.9% vs. 3.0%
respectively). Compared to the placebo group, the zonisamide group reported a
more frequent decrease in appetite (6.5% vs. 4.0%), weight loss (4.7% vs. 3.0%),
somnolence (4.7% vs. 2.0%), vomiting (3.7% vs. 2.0%) and diarrhea (3.7% vs. 1.0%).
About
Epilepsy
An estimated six million people in Europe live with
epilepsy, one of the most common neurological conditions in the world, affecting
approximately 8 in 1,000 Europeans. Worldwide it is estimated that 50 million
people suffer from epilepsy, 10.5 million of which are children under the age of
15.
Epilepsy is defined as abnormal firing of impulses from nerve cells
in the brain that cause seizures, which depending on the type of seizure, may be
limited to one part of the body, or may involve the entire body.
Other
characteristics of epilepsy may be the experience of abnormal sensations,
altered behavior or altered consciousness. There are many possible causes for
this disorder and the reasons for epilepsy often remain undiscovered, however,
anything disturbing the normal pattern of neuron activity, such as illness,
brain damage or tumors can lead to seizures.
