paul.nowak wrote: Matt, thanks for the comments. I made an error on the version of Plone. It's 2.5 Plone running on Zope 2.9x.
In regards to the additional products, we have a skin installed and we have a product that we had custom developed for us that connects to a PostgreSQL database. We've looked at slow PostgreSQL queries causing problems and have not been able to find an issue. We've also tested for the case where the PostgreSQL server is down and have not been able to create an issue. We therefor...
UCB Announces Positive Top-Line Phase III Results for Keppra(R) as Adjunctive Therapy for Partial Onset Seizures in Paediatric Patients from One Month to Less than Four Years of Age
UCB Announces Positive Top-Line Phase III Results for Keppra(R) as Adjunctive Therapy for Partial Onset Seizures in Paediatric P
Brussels, Belgium - April 20, 2007 at 7:00 AM CET - UCB
today
announced positive top-line results from a phase III, double-
blind,
randomized, multi-centre, placebo-controlled study evaluating
the
efficacy and tolerability of Keppra® (levetiracetam) (20-
50
mg/kg/day) as adjunctive therapy in the treatment of partial
onset
seizures in children (n=116) from one month to less than four
years
of age. Compared with placebo, Keppra® was shown to
significantly
reduce the frequency of partial onset seizures in these
paediatric
patients with consistent results across all stratified age groups.
Commenting on the results, Jesús Eric Piña-Garza M.D., Professor
of
Paediatric Neurology & Director Pediatric Epilepsy Clinical
Trials,
Vanderbilt University, Nashville, Tennessee said 'There are very
few
studies assessing antiepileptic drug efficacy in infants. In
this
well-designed randomized trial Keppra® was shown to be
more
efficacious than placebo in controlling partial seizures in
infants
and young children with treatment resistant partial onset
epilepsies.
This study is a welcome addition to current information in
paediatric
epilepsy.'
In this study 43.1% of Keppra®-treated patients experienced at
least
a 50% reduction in seizure frequency during the evaluaton
period
(five days) compared with 19.6% of placebo-treated patients. The
most
common treatment-emergent adverse events that occurred
in
Keppra®-treated patients and more frequently than placebo-
treated
patients were somnolence and irritability. Prior to
treatment
children in this study were experiencing at least two partial
onset
seizures per week despite treatment with one or two
other
antiepileptic drugs. Efficacy assessment was based on 48 hour
video
EEG performed at baseline and at the end of the evaluation
period
with seizures identified and recorded by a central reader.
Fifty million people worldwide have epilepsy[2]. Childhood
epilepsy
is among the most prevalent neurological conditions. The effects
of
epilepsy on a child's psychological and social development
are
complex and cover all dimensions of a child's life and future.
Peter Verdru, Vice President, CNS Clinical Development, UCB
said,
'This is the second double-blind, randomized, placebo-
controlled
trial of Keppra® in children, with studies in partial onset
seizures
now extending from infancy through adulthood.' He continued,
'This
trial was designed and conducted in close collaboration with
the
regulatory authorities. On the basis of these positive results
in
younger patients with treatment resistant partial seizures we
intend
to file a supplementary new drug application for Keppra®'.
About Keppra® in the US[3],[4]
Keppra® tablets and oral solution are indicated as adjunctive
therapy
in the treatment of partial onset seizures in adults and children
4
years of age and older with epilepsy, as adjunctive therapy in
the
treatment of myoclonic seizures in adults and adolescents 12 years
of
age and older with juvenile myoclonic epilepsy, and as
adjunctive
therapy in the treatment of primary generalized tonic-clonic
seizures
in adults and children 6 years of age and older with
idiopathic
generalized epilepsy (IGE). Keppra® tablets and oral solution
are
associated with the occurrence of central nervous system
adverse
events including somnolence and fatigue, co-ordination
difficulties
and behavioral abnormalities as well as hematological
abnormalities.
In adults experiencing partial onset seizures, the most
common
adverse events associated with Keppra® in combination with
other
antiepileptic drugs (AEDs) were somnolence, asthenia, infection
and
dizziness. In pediatric patients 4-16 years of age
experiencing
partial onset seizures, the most common adverse events
associated
with Keppra® in combination with other antiepileptic drugs
(AEDs)
were somnolence, accidental injury, hostility, nervousness
and
asthenia. In patients 12 years of age and older with
juvenile
myoclonic epilepsy, the most common adverse events associated
with
Keppra® in combination with other AEDs were somnolence, neck pain
and
pharyngitis. In patients 6 years of age and older with
idiopathic
generalized epilepsy experiencing primary generalized tonic-
clonic
seizures, the most common adverse event associated with Keppra®
in
combination with other AEDs was nasopharyngitis. Keppra® is
also
available as an intravenous formulation for the adjunctive
treatment
of partial-onset seizures in adults with epilepsy. Keppra®
injection
is an alternative for patients when oral administration
is
temporarily not feasible. The adverse events that may result
from
Keppra® injection use for partial onset seizures include all
those
associated with Keppra® tablets and oral solution. For the
U.S.,
prescribing information is available at www.keppra.com.
About Keppra® in Europe[5]
Keppra® is indicated as monotherapy in the treatment of partial
onset
seizures with or without secondary generalisation in patients
from
16 years of age with newly diagnosed epilepsy; as adjunctive
therapy
in the treatment of partial onset seizures with or without
secondary
generalisation in adults and children from 4 years of age
with
epilepsy; as adjunctive therapy in the treatment of
myoclonic
seizures in adults and adolescents from 12 years of age with JME
and
as adjunctive therapy in the treatment of PGTC seizures in adults
and
adolescents from 12 years of age with IGE. In monotherapy the
most
commonly reported undesirable effects were fatigue and somnolence.
As
adjunctive therapy in adults with partial onset seizures the
most
commonly reported undesirable effects were somnolence, asthenia
and
dizziness. As adjunctive therapy in paediatric patients (4-16
years
of age) with partial onset seizures the most commonly
reported
undesirable effects were somnolence, hostility,
nervousness,
emotional lability, agitation, anorexia, asthenia and headache.
In
adults and adolescents with myoclonic seizures the most
common
reported undesirable effects associated with Keppra® in
combination
with other AEDs were headache and somnolence. In adults
and
adolescents with primary generalized tonic-clonic seizures the
most
common reported undesirable effects associated with Keppra®
in
combination with other AEDs was fatigue. Keppra® is also
indicated
for intravenous administration and is available as 100
mg/mL
concentrate for solution for infusion. Undesirable effects
that
resulted from Keppra® intravenous use are similar to those
associated
with Keppra® oral use. Please consult local prescribing
information.
About UCB
Headquartered in Brussels (Belgium), UCB (www.ucb-group.com) is
a
leading global biopharmaceutical company dedicated to the
research,
development and commercialisation of innovative pharmaceutical
and
biotechnology products in the fields of central nervous
system
disorders, allergy/respiratory diseases, immune and
inflammatory
disorders and oncology - UCB focuses on securing a leading
position
in severe disease categories. Employing more than 8400 people
in
over 40 countries, UCB achieved revenue of 2.5 billion euro in
2006.
UCB is listed on the Euronext Brussels Exchange and owns 87.6%
of
Schwarz Pharma.
For further enquiries, please contact
Jean-Christophe Donck Mareike Mohr
Vice President, Associate Director, Investor
Relations
Corporate Communications and
Investor Relations
Tel. +32 2 559 9346 Tel. +32 2 559 9264
References
[1] UCB Data on File
[2] Neurological Disorders: Public Health Challenges. WHO Report
1986
[3] U.S. Prescribing Information Keppra® tablets and oral solution
(24E) (available at www.Keppra.com).
[4] U.S. Prescribing Information Keppra® injection (2E) (available
at www.Keppra.com).
[5] Keppra® Summary of Product Characteristics, January 2007
(available at www.emea.eu.int).
For the pdf-version of this press release, please click on the
link
below: