MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist
- Conditions
- Idiopathic Parkinson's Disease
- Interventions
- Registration Number
- NCT00605683
- Lead Sponsor
- Newron Pharmaceuticals SPA
- Brief Summary
Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man.
This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease.
The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 679
- Diagnosis of idiopathic Parkinson's Disease of less than 5 years duration, with a Hoehn and Yahr stage of I-III. The diagnosis should be based on medical history and neurological examination.
- 30 to 80 years, inclusive, at screening.
- If female, be either post menopausal for at least 2 years, surgically sterilised or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and four weeks after the last dose of study medication. For the purposes of this study, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive.
- Receiving treatment with a single dopamine agonist at a stable dose for at least 4 weeks prior to the screening visit.
- Willing and able to participate in the study and have provided written, informed consent.
To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
- Any indication of forms of Parkinsonism, other than idiopathic Parkinson's Disease.
- If female, be pregnant or lactating.
- Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months.
- Currently experiencing end of dose wearing off or on-off phenomena, disabling peak dose or biphasic dyskinesias, or unpredictable or widely swinging fluctuations.
- Current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including acute gastric ulcer, hypertension that is not well controlled, asthma, chronic obstructive pulmonary disease (COPD), and Type I diabetes. Subjects with a history of gastric ulcer who have not had a recent episode of acute gastritis and are not currently experiencing gastric pain will be eligible for inclusion.
- Second- or third-degree atrioventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, or significant ECG abnormality, including QTc ≥ 450 msec (males) or ≥ 470 msec (females), where QTc is based on Bazett's correction method.
- Have received treatment with safinamide previously.
- Concomitant disease likely to interfere with the study medication (e.g. capable of altering absorption, metabolism or elimination of the study drug).
- History of, or current psychosis (e.g. schizophrenia or psychotic depression) or a score ≥ 3 on item 2 (thought disorder) or 3 (depression) of the UPDRS, Section I at screening.
- Evidence of dementia or cognitive dysfunction, as indicated by a MMSE score < 24 or a score ≥ 3 on item 1 (mentation) of the UPDRS, Section I at screening.
- Depression, as indicated by a GRID-HAMD (17-item scale) score > 17 at screening.
- History of allergic response to anticonvulsants or anti-Parkinsonian agents.
- Mental or physical condition (e.g., neurotic behaviour, crippling degenerative arthritis, or limb amputation), which would preclude performing efficacy or safety assessments.
- Hypersensitivity or contraindications to MAO B inhibitors.
- Current history of severe dizziness or fainting on standing, due to postural hypotension.
- Neoplastic disorder, which is either currently active or has been in remission for less than one year.
- Participation in a clinical trial within 30 days of entry into the trial (screening visit) or has received treatment with any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to screening.
- Treatment of their Parkinsonian symptoms with a medication, other than a stable dose of a single dopamine agonist, during the 8 weeks preceding the screening visit.
- Treatment with any agent known to significantly inhibit or induce drug-metabolising enzymes (e.g., barbiturates, phenothiazines, etc.) within 4 weeks preceding the screening visit.
- Treatment with opioids (e.g., tramadol, meperidine derivatives), SNRIs (e.g., venlafaxine, duloxetine), tri- or tetra-cyclic antidepressants, MAO inhibitors (e.g. selegiline), in the 8 weeks prior to the screening visit. Dextromethorphan will be permitted if used for treating cough.
- Treatment with a depot neuroleptic within one injection cycle, or oral neuroleptics within 4 weeks prior to the screening visit.
- Treatment with a drug that has hepatotoxic potential, e.g., tamoxifen, within 4 weeks, or received radiation therapy or a drug with cytotoxic potential, e.g., chemotherapy, within one year prior to the screening visit.
- Diagnosis of HIV, or tests positive for Hepatitis C antibodies, or Hepatitis B surface antigen.
- Any abnormality that the investigator deems to be clinically relevant, either on medical history, physical examination, ECG or in a diagnostic laboratory test.
- Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy.
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Safinamide (as add-on therapy) 50 mg/day Safinamide 2 Safinamide (as add-on therapy) Safinamide 100mg/day 3 Safinamide (as add-on therapy) Placebo 0mg/Safinamide
- Primary Outcome Measures
Name Time Method Evaluate the changes from baseline to W24 in motor symptoms (UPDRS Section III). 24 weeks
- Secondary Outcome Measures
Name Time Method Evaluate the changes from baseline to W24 in activities of daily living, cognition, change in global clinical status, responder rates with regard to motor symptoms and health related quality of life 24 weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (125)
Parkinson's Disease and Movement Disorder Center
🇺🇸Boca Raton, Florida, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Parkinson's Disease and Movement Disorders Center of Albany
🇺🇸Albany, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Pacific Neuroscience Medical Group
🇺🇸Oxnard, California, United States
Columbus Research Institute
🇺🇸Columbus, Georgia, United States
Neurologic Consultants P.A.
🇺🇸Ft Lauderdale, Florida, United States
Parkinson's Disease Treatment Center of SW Florida
🇺🇸Port Charlotte, Florida, United States
Arizona Neurological Institute
🇺🇸Phoenix, Arizona, United States
University Of Florida
🇺🇸Gainesville, Florida, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Parkinson's Institute
🇺🇸Sunnyvale, California, United States
Neurology Clinical Research Inc.
🇺🇸Sunrise, Florida, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Hospital das Clinicas da UFPR
🇧🇷Curitiba, Brazil
Northwestern University PD and Movement Disorders Center
🇺🇸Chicago, Illinois, United States
Instituto de Neurociencias Buenos Aires S.A.
🇦🇷Buenos Aires, Argentina
Centre For Movement Disorders
🇨🇦Markham, Canada
Parkinson's and Neurodegenerative Disorders Clinic
🇨🇦Ottawa, Canada
University Of South Florida Medical Center
🇺🇸Tampa, Florida, United States
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
North Shore Medical Center
🇺🇸Manhasset, New York, United States
New York University
🇺🇸New York, New York, United States
Duke University Health Systems
🇺🇸Druham, North Carolina, United States
Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Butler Hospital
🇺🇸Providence, Rhode Island, United States
Hospital Español
🇦🇷Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Capital Federal, Argentina
Clinica IMECO
🇦🇷Capital Federal, Argentina
Instituto de Investigaciones Neurológicas Raul Carrea FLENI
🇦🇷Capital Federal, Argentina
Instituto Frenopatico S.A.
🇦🇷Capital Federal, Argentina
Instituto Medico Congreso
🇦🇷Ciudad Autonoma de Bs. As., Argentina
Hospital Privado Centro Médico de Córdoba
🇦🇷Cordoba, Argentina
Instituto Argentino de Investigacion Neurologica SRL
🇦🇷Ciudad Autonoma de, Argentina
Instituto INEBA
🇦🇷Ciudad Autónoma de Bs. As., Argentina
Hospital Universitario Austral
🇦🇷Pilar, Argentina
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Brazil
Centro Pediatrico Professor Hosanna de Oliveira
🇧🇷Salvador, Brazil
Hospital Universitario Professor Edgard Santos - UFBA
🇧🇷Salvador, Brazil
CCB Medical Institute - Ministry of Interior
🇧🇬Sofia, Bulgaria
First MHAT - Sofia AD
🇧🇬Sofia, Bulgaria
MHAT Tokuda Hospital Sofia AD
🇧🇬Sofia, Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL' EAD
🇧🇬Sofia, Bulgaria
Dynamik Research Inc.
🇨🇦Pointe-Claire, Quebec, Canada
SHATNP 'Sv. Naum' EAD
🇧🇬Sofia, Bulgaria
Kingston General Hospital
🇨🇦Kingston, Canada
Toronto Western Hospital - University Health Network
🇨🇦Toronto, Canada
Hospital Barros Luco Trudeau
🇨🇱Santiago, Chile
Clinica Ciudad del Mar
🇨🇱Viña del Mar, Chile
Fundación Clínica Abood Shaio
🇨🇴Bogotá, Colombia
Centro de Investigaciones del Sistema Nervioso Limitada
🇨🇴Bogota, Colombia
Hospital Base Valdivia
🇨🇱Valdivia, Chile
Clinical Hospital Center Rijeka
🇭🇷Rijeka, Croatia
Instituto del Corazón
🇨🇴Bucaramanga, Colombia
Clinical Hospital "Sestre Milosrdnice"
🇭🇷Zagreb, Croatia
Clinical Hospital Osijek
🇭🇷Osijek, Croatia
Clinical Hospital Centre Zagreb
🇭🇷Zagreb, Croatia
Privatni neurologicka ambulance
🇨🇿Hradec Kralove, Czech Republic
Poliklinika Modry pavilon
🇨🇿Ostrava, Czech Republic
VFN Praha
🇨🇿Praha 2, Czech Republic
Clintrials.r.o.
🇨🇿Praha 10, Czech Republic
Etelä-Karjalan keskussairaala
🇫🇮Lappeenranta, Finland
ODL Terveys Oy
🇫🇮Oulu, Finland
Krishna Institute of Medical Sciences
🇮🇳Hyderabad, India
Nizam's Institute of Medical Sciences
🇮🇳Hyderabad, India
Eberhard-Karls-Universitaet
🇩🇪Tuebingen, Germany
Poona Hospital & Research Center
🇮🇳Pune, India
Mallikatta Neuro and Research Centre
🇮🇳Mangalore', India
All India Institute of Medical Sciences (AIIMS)
🇮🇳New Delhi, India
AO Universitaria Policlinico di Catania
🇮🇹Catania, Italy
Andhra Medical College
🇮🇳Vishakapatnam, India
Fondazione Università Gabriele D'Annunzio
🇮🇹Chieti, Italy
Ospedale Versilia
🇮🇹Lido di Camaiore, Italy
Istituti Clinici di Perfezionamento
🇮🇹Milano, Italy
Fondazione San Raffaele del Monte Tabor
🇮🇹Milano, Italy
IRCCS S. Raffaele Pisana
🇮🇹Roma, Italy
Università degli Studi "Federico II"
🇮🇹Napoli, Italy
Policlinico Tor Vergata
🇮🇹Roma, Italy
Ospedale San Giovanni Battista Ordine di Malta
🇮🇹Roma, Italy
Azienda Ospedaliera Universitaria di Parma
🇮🇹Parma, Italy
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
🇲🇽Guadalajara, Mexico
Medical Sur
🇲🇽Mexico, Mexico
Hospital Alberto Sabogal Sologuren
🇵🇪Callao, Peru
Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Pomorskie Centr.Traumatologii WSS im.M.Kopernika
🇵🇱Gdansk, Poland
Poliklinika Tehelna
🇸🇰Bratislava, Slovakia
Fakultna nemocnica Trnava
🇸🇰Trnava, Slovakia
Vseobecna nemocnica s poliklinikou Levoca a.s.
🇸🇰Levoca, Slovakia
Nestatne zdravotnicke zariadenie
🇸🇰Zilina, Slovakia
Sandton Clinic
🇿🇦Johannesburg, Gauteng, South Africa
Constantiaberg Medi-Clinic
🇿🇦Cape Town, South Africa
Dr CC Coetzee Inc
🇿🇦Durban, KZ-Natal, South Africa
Willows Medical Centre
🇿🇦Pretoria, South Africa
H Clinic i Provincial
🇪🇸Barcelona, Spain
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Fundacion H. Alcorcon
🇪🇸Madrid, Spain
H Mutua de Terrassa
🇪🇸Barcelona, Spain
Policlinica Guipuzcoa
🇪🇸San Sebastian, Spain
Neurology Specialists
🇺🇸Dayton, Ohio, United States
Shatcvd - Nch Ead
🇧🇬Sofia, Bulgaria
H de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Groote Schuur Hospital
🇿🇦Cape Town, South Africa
San Francisco Clinical Research Center
🇺🇸San Francisco, California, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Ehret Reinhard
🇩🇪Berlin, Germany
Charité Universitaetsmedizin Berlin - Campus Charité Mitte
🇩🇪Berlin, Germany
St. Josef-Hospital
🇩🇪Berlin, Germany
St. Augustine's Medical Mews
🇿🇦Durban, South Africa
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Baylor College of Medicine
🇺🇸Houston, Texas, United States
MU Dr. Beata Dupejova Neurologicka ambulancia s.r.o
🇸🇰Banska Bystrica, Slovakia
Itä-Suomen yliopisto Kuopion kampus
🇫🇮Kuopio, Finland
T.N. Medical College & B.Y.L. Nair Hospital
🇮🇳Mumbai, India
Instituto Nacional de Neurologia
🇲🇽Colonia La Fama, Mexico
Instituto de Información de Investigación en Salud Mental
🇲🇽Monterrey, Mexico
Clinica Anglo Americana
🇵🇪Lima, Peru
Hospital Nacional Guillermo Almenara Irigoyen
🇵🇪Lima, Peru
Fakultni nemocnice Brno
🇨🇿Brno, Czech Republic
Brain & Mind Institute
🇮🇳Nagpur, India
FNsP Bratislava pracovisko Kramare
🇸🇰Bratislava, Slovakia
Institute for Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States
The Neurological Institute
🇺🇸Charlotte, North Carolina, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States