Merck Serono Completes Patient Enrollment in MOTION, a Phase III Pivotal Clinical Trial of Safinamide in Early Parkinson’s Disease
By Merck Serono S A, PRNETuesday, June 28, 2011
GENEVA, Switzerland, June 29, 2011 -
- Study will evaluate safety and efficacy of safinamide as
add-on to dopamine agonist therapy in early
Parkinson‘s disease
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, and
its partner Newron Pharmaceuticals S.p.A announced today that
patient enrollment has been completed in the
MOTION[1] study. This randomized,
double-blind, placebo-controlled, international phase III pivotal
trial is designed to evaluate the efficacy and safety of two dose
regimens of safinamide (50 and 100 mg once daily), as add-on
therapy to a stable dose of a single dopamine agonist, compared
with dopamine agonist monotherapy. A total of 679 patients with
early-stage Parkinson’s disease have been randomized in the
study.
“The completion of enrollment into the MOTION Phase III trial in
early stage Parkinson’s disease represents another step forward in
our clinical development program of safinamide,” said Dr. Bernhard
Kirschbaum, Merck Serono’s Head of Global Research and Development.
“Our goal is to provide a new treatment option to patients with
Parkinson’s disease, a neurodegenerative disease with a high
remaining unmet medical need.”
The MOTION study is part of the clinical development program of
safinamide in Parkinson’s disease, together with completed studies
015, 016, 017 and 018, as well as the ongoing SETTLE study. This
clinical program is designed to investigate safinamide as an add-on
therapy to dopamine agonist therapy in patients with early
Parkinson’s disease and as an add-on to levodopa therapy in
patients with advanced Parkinson’s disease.
Merck Serono has exclusive worldwide rights to develop,
manufacture and commercialize safinamide in Parkinson’s disease,
Alzheimer’s disease and other therapeutic applications, as per the
agreement signed with Newron in 2006.
[1]MOTION: SafinaMide add-On To
dopamine agonist for early Idiopathic ParkinsON’s disease with
motor fluctuations
MOTION study design
The study is a six-month (24-week), randomized, double-blind,
placebo-controlled international Phase III trial. It enrolled 679
patients with early idiopathic Parkinson’s disease (less than five
years of disease duration) treated with a stable dose of a single
dopamine agonist for at least four weeks. Study participants were
randomized in one of the three arms of the trial (1:1:1), to
receive either safinamide 50 mg once daily, safinamide 100 mg once
daily or matching placebo tablets, as adjunctive treatment to
dopamine agonist therapy.
The primary endpoint of the trial is the change in motor
symptoms assessed by the change in the Unified Parkinson’s Disease
Rating Scale (UPDRS) Part III score from baseline to week 24.
Secondary endpoints include changes in measures of activities of
daily living, cognitive functions, global clinical status and
health-related quality of life.
About safinamide
Safinamide is an alpha-aminoamide that is currently being
developed by Merck Serono and Newron as an add-on therapy to
dopamine agonists or to levodopa in patients with early or mid- to
late-stage Parkinson’s disease (PD). It is believed to have both
dopaminergic and non-dopaminergic activities, including selective
and reversible inhibition of monoamine oxidase B (MAO-B),
activity-dependent sodium channel antagonism and inhibition of
glutamate release in vitro. Studies are ongoing to better
understand safinamide’s actions in patients with PD.
Safinamide is currently in Phase III for PD and its clinical
program includes:
- The ongoing MOTION (safinaMide add-On To dopamine agonists for
early Idiopathic ParkinsON’s) study: a phase III, double-blind,
placebo-controlled randomized six-month trial to evaluate efficacy
and safety of two doses of safinamide (50mg/day or 100 mg/day), as
add-on to dopamine agonist therapy versus dopamine agonist therapy
alone, in early stage PD patients and the MOTION extension 18-month
phase III, double-blind, placebo-controlled extension study
designed to provide data on the long-term safety and efficacy.
- The ongoing SETTLE (SafinamidE Treatment as add-on To
LEvodopa) study: a Phase III, double-blind, placebo-controlled
six-month trial to evaluate efficacy and safety of a dose range of
safinamide (50-100 mg/day) as add-on to levodopa therapy versus
levodopa therapy alone, in mid- to late-stage PD patients.
- The completed 015 study: a phase III, double-blind,
placebo-controlled six-month study to evaluate efficacy and safety
of a low (50-100mg/day) and high (150-200mg/day) dose range of
safinamide as add-on to dopamine agonist therapy versus dopamine
agonist therapy alone in early stage PD patients.
- The completed 017 study (the 015 extension study): a phase
III, double-blind, placebo-controlled, 12-month extension study to
evaluate the long-term efficacy and safety of a dose range of
safinamide of 50-200mg/day, as add-on to dopamine agonist therapy
versus dopamine agonist therapy alone in early stage PD
patients.
- The completed 016 study: a phase III, double-blind,
placebo-controlled randomized six-month trial to evaluate efficacy
and safety of two doses safinamide (50mg/day or 100mg/day) as
add-on to levodopa therapy versus levodopa therapy alone, in
patients with mid- to late-stage PD experiencing motor
fluctuations.
- The completed 018 study (the 016 extension study): a phase
III, double-blind, randomized, placebo-controlled, 18-month
extension to Study 016, to evaluate the long-term efficacy and
safety of two doses safinamide (50mg/day or 100mg/day) as add-on to
levodopa therapy versus levodopa therapy alone, in patients with
mid- to late-stage PD experiencing motor fluctuations.
About Parkinson‘s disease
Parkinson’s disease is a degenerative disorder of the central
nervous system that often impairs the patient’s motor skills and
speech. Parkinson’s disease belongs to a group of conditions called
movement disorders. It is characterized by muscle rigidity, tremor,
a slowing of physical movement (bradykinesia) and, in extreme
cases, a loss of physical movement (akinesia). The primary symptoms
are the results of decreased stimulation of the motor cortex by the
basal ganglia, normally caused by the insufficient formation and
action of dopamine, which is produced in the dopaminergic neurons
of the brain. Secondary symptoms may include high-level cognitive
dysfunction and subtle language problems. Parkinson’s disease is
both chronic and progressive. It is estimated that more than 3
million people in the industrialized countries suffer from
Parkinson’s disease.
About Merck Serono
Merck Serono is the biopharmaceutical division of Merck KGaA,
Darmstadt, Germany, a global pharmaceutical and chemical company.
Headquartered in Geneva, Switzerland, Merck Serono discovers,
develops, manufactures and markets prescription medicines of both
chemical and biological origin in specialist indications. In the
United States and Canada, EMD Serono operates as a separately
incorporated affiliate of Merck Serono.
Merck Serono has leading brands serving patients with cancer
(Erbitux®, cetuximab), multiple sclerosis (Rebif®, interferon
beta-1a), infertility (Gonal-f®, follitropin alfa), endocrine and
metabolic disorders (Saizen® and Serostim®, somatropin), (Kuvan®,
sapropterin dihydrochloride), (Egrifta™, tesamorelin), as well as
cardiometabolic diseases (Glucophage®, metformin), (Concor®,
bisoprolol), (Euthyrox®, levothyroxine). Not all products are
available in all markets.
With an annual R&D expenditure of over € 1bn, Merck Serono
is committed to growing its business in specialist-focused
therapeutic areas including neurodegenerative diseases, oncology,
fertility and endocrinology, as well as new areas potentially
arising out of research and development in rheumatology.
About Merck
Merck is a global pharmaceutical and chemical company with total
revenues of € 9.3 billion in 2010, a history that began in 1668,
and a future shaped by more than 40,000 employees in 67 countries.
Its success is characterized by innovations from entrepreneurial
employees. Merck’s operating activities come under the umbrella of
Merck KGaA, in which the Merck family holds an approximately 70%
interest and free shareholders own the remaining approximately 30%.
In 1917 the U.S. subsidiary Merck & Co. was expropriated and
has been an independent company ever since.
For more information, please visit www.merckserono.com or
www.merck.de
Merck Serono S.A. - Geneva, 9 Chemin des Mines, 1202 Genève, Suisse, Media relations, Tel: +41-22-414-36-00,
Tags: Geneva, June 29, Merck Serono S A, Switzerland
