Lundbeck Initiates Clinical Trial Evaluating Clobazam for Dravet Syndrome
18 March 2015 - 1:00AM
Business Wire
Lundbeck LLC today announced the initiation of the CLOVER I
Study to investigate the use of clobazam for the treatment of
children and adolescents with Dravet syndrome — a rare and severe
form of intractable epilepsy that begins in infancy.1 Clobazam is
already approved in the United States (U.S.) for seizures
associated with another epilepsy syndrome.
“Dravet syndrome is one of the more challenging forms of
epilepsy and has a profound impact on an individual’s life,
requiring constant care that can take a significant emotional toll
on caregivers,” said Elaine Wirrell, MD, lead investigator of the
study and pediatric neurologist at the Mayo Clinic. “The CLOVER I
Study will help us better understand the effect of clobazam on
Dravet syndrome in this patient population, and hopefully provide
more information for both physicians and their families when
considering treatment options.”
The CLOVER I Study is designed to evaluate the efficacy, safety
and tolerability of clobazam as adjunctive therapy in pediatric
patients aged one to 16 years of age with Dravet syndrome. The
primary objective of the study is to investigate the effect of
clobazam on the frequency of tonic-clonic and clonic seizures after
16 weeks of treatment.2 The multicenter study will enroll 54
patients in approximately 25 sites in three countries: Argentina,
Mexico and the United States.3 At the end of the study,
participants may have the option of joining the CLOVER II study (a
52-week, open-label extension study).
“Lundbeck has a deep commitment to the epilepsy community, with
a particular focus on those living with rare forms of epilepsy
associated with frequent, severe seizures,” said Deborah Lee, MD,
PhD, senior medical director, clinical research at Lundbeck in the
U.S. “As a pediatric neurologist, I am particularly driven to
address the needs of these courageous patients who take on so much
adversity at such a young age.”
For more information about the CLOVER I study, visit
www.lundbeck.com/clintrialrecruit or contact Lundbeck at
866.402.8520.
About Dravet syndrome
Dravet syndrome is a rare and severe form of intractable
epilepsy that typically begins in the first year of life in an
otherwise healthy infant and persists into adulthood.1,4 It is also
known as Severe Myoclonic Epilepsy of Infancy (SMEI).1 Most
children have some level of behavioral and developmental delays
that begin in the second year of life.1 Other conditions that are
associated with the syndrome include movement and balance issues,
orthopedic conditions, chronic infections and delayed language and
speech issues, among others.1 There are currently no treatments
approved by the U.S. Food and Drug Administration (FDA) for the
treatment of Dravet syndrome.
About Lundbeck in the U.S.
Lundbeck in the U.S., headquartered in Deerfield, Illinois, is a
wholly-owned subsidiary of H. Lundbeck A/S in Denmark. Globally,
our mission is to help people suffering from psychiatric and
neurologic disorders. To drive this mission in the U.S., nearly 800
employees are engaged in the research, development, production,
marketing and sale of innovative specialty therapies that fulfill
unmet medical needs. We see the person behind the disease and how
it affects the lives of patients, families and caregivers. Lundbeck
is actively involved with hundreds of local and national U.S.
events each year that support our patient communities. To learn
more, visit us at www.LundbeckUS.com and connect with us on Twitter
at @LundbeckUS.
About H. Lundbeck A/S
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global
pharmaceutical company specialized in brain diseases. For more than
50 years, we have been at the forefront of research within
neuroscience. Our development and distribution of pioneering
treatments continues to make a difference to people living with
brain diseases. Our key areas of focus are alcohol dependence,
Alzheimer's disease, depression/anxiety, epilepsy, Huntington's
disease, Parkinson's disease, schizophrenia and stroke.
Our approximately 6,000 employees in 57 countries are engaged in
the entire value chain throughout research, development,
production, marketing and sales, and are committed to improving the
quality of life of people living with brain diseases. Our pipeline
consists of several late-stage development programs and our
products are available in more than 100 countries. We have research
centers in China, Denmark and the United States, and production
facilities in China, Denmark, France, Italy and Mexico. Lundbeck
generated revenue of approximately DKK 15 billion in 2013 (EUR 2.0
billion; USD 2.7 billion).
Lundbeck’s shares are listed on the stock exchange in Copenhagen
under the symbol “LUN”. Lundbeck has a sponsored Level 1 ADR
program listed in the US (OTC) under the symbol “HLUYY”. For
additional information, we encourage you to visit our corporate
site www.lundbeck.com.
Sources
1. Dravet Syndrome Foundation. What is Dravet Syndrome?
http://www.dravetfoundation.org/dravet-syndrome/what-is-dravet-syndrome.
Last accessed 12/12/14.
2. U.S. National Institutes of Health. Clobazam as Adjunctive
Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet
Syndrome. https://clinicaltrials.gov/ct2/show/NCT02174094. Last
accessed 12/12/14.
3. Lundbeck Data on File.
4. Epilepsy.com. Dravet Syndrome.
http://www.epilepsy.com/learn/types-epilepsy-syndromes/dravet-syndrome.
Last accessed 12/12/14.
CLB-C-00003
LundbeckMatt Flesch, (847) 922-2871
H Lundbeck AS (PK) (USOTC:HLUYY)
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