MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist
NCT ID: NCT00605683
Last Updated: 2013-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
679 participants
INTERVENTIONAL
2007-11-30
2012-03-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
50 mg/day Safinamide
Safinamide (as add-on therapy)
Safinamide, (S)-(+)-2-\[4-(3-fluorobenzyloxy) benzylamino\] propanamide methanesulfonate, is an a-aminoamide derivative
2
Safinamide 100mg/day
Safinamide (as add-on therapy)
Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist
3
Placebo 0mg/Safinamide
Safinamide (as add-on therapy)
Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist
Interventions
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Safinamide (as add-on therapy)
Safinamide, (S)-(+)-2-\[4-(3-fluorobenzyloxy) benzylamino\] propanamide methanesulfonate, is an a-aminoamide derivative
Safinamide (as add-on therapy)
Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist
Safinamide (as add-on therapy)
Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 30 to 80 years, inclusive, at screening.
3. 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.
4. Receiving treatment with a single dopamine agonist at a stable dose for at least 4 weeks prior to the screening visit.
5. Willing and able to participate in the study and have provided written, informed consent.
Exclusion Criteria
1. Any indication of forms of Parkinsonism, other than idiopathic Parkinson's Disease.
2. If female, be pregnant or lactating.
3. Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months.
4. Currently experiencing end of dose wearing off or on-off phenomena, disabling peak dose or biphasic dyskinesias, or unpredictable or widely swinging fluctuations.
5. 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.
6. 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.
7. Have received treatment with safinamide previously.
8. Concomitant disease likely to interfere with the study medication (e.g. capable of altering absorption, metabolism or elimination of the study drug).
9. 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.
10. 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.
11. Depression, as indicated by a GRID-HAMD (17-item scale) score \> 17 at screening.
12. History of allergic response to anticonvulsants or anti-Parkinsonian agents.
13. Mental or physical condition (e.g., neurotic behaviour, crippling degenerative arthritis, or limb amputation), which would preclude performing efficacy or safety assessments.
14. Hypersensitivity or contraindications to MAO B inhibitors.
15. Current history of severe dizziness or fainting on standing, due to postural hypotension.
16. Neoplastic disorder, which is either currently active or has been in remission for less than one year.
17. 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.
18. 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.
19. 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.
20. 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.
21. Treatment with a depot neuroleptic within one injection cycle, or oral neuroleptics within 4 weeks prior to the screening visit.
22. 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.
23. Diagnosis of HIV, or tests positive for Hepatitis C antibodies, or Hepatitis B surface antigen.
24. Any abnormality that the investigator deems to be clinically relevant, either on medical history, physical examination, ECG or in a diagnostic laboratory test.
25. 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.
26. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
30 Years
80 Years
ALL
No
Sponsors
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Newron Pharmaceuticals SPA
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Willmer, MD
Role: STUDY_DIRECTOR
Merck Serono S.A., Geneva
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Neurological Institute
Phoenix, Arizona, United States
Pacific Neuroscience Medical Group
Oxnard, California, United States
San Francisco Clinical Research Center
San Francisco, California, United States
Parkinson's Institute
Sunnyvale, California, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Parkinson's Disease and Movement Disorder Center
Boca Raton, Florida, United States
Neurologic Consultants P.A.
Fort Lauderdale, Florida, United States
University Of Florida
Gainesville, Florida, United States
Parkinson's Disease Treatment Center of SW Florida
Port Charlotte, Florida, United States
Neurology Clinical Research Inc.
Sunrise, Florida, United States
University Of South Florida Medical Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Columbus Research Institute
Columbus, Georgia, United States
Northwestern University PD and Movement Disorders Center
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Parkinson's Disease and Movement Disorders Center of Albany
Albany, New York, United States
North Shore Medical Center
Manhasset, New York, United States
Columbia University Medical Center
New York, New York, United States
New York University
New York, New York, United States
The Neurological Institute
Charlotte, North Carolina, United States
Duke University Health Systems
Druham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Neurology Specialists
Dayton, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Lankenau Hospital
Wynnewood, Pennsylvania, United States
Butler Hospital
Providence, Rhode Island, United States
Baylor College of Medicine
Houston, Texas, United States
Hospital Español
Buenos Aires, , Argentina
Instituto de Neurociencias Buenos Aires S.A.
Buenos Aires, , Argentina
Clinica IMECO
Capital Federal, , Argentina
Hospital Italiano de Buenos Aires
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
Instituto Argentino de Investigacion Neurologica SRL
Ciudad Autonoma de, , Argentina
Instituto INEBA
Ciudad Autónoma de Bs. As., , Argentina
Hospital Privado Centro Médico de Córdoba
Córdoba, , Argentina
Hospital Universitario Austral
Pilar, , Argentina
Hospital das Clinicas da UFPR
Curitiba, , Brazil
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
Shatcvd - Nch Ead
Sofia, , Bulgaria
SHATNP 'Sv. Naum' EAD
Sofia, , Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL' EAD
Sofia, , Bulgaria
Dynamik Research Inc.
Pointe-Claire, Quebec, Canada
Kingston General Hospital
Kingston, , Canada
Centre For Movement Disorders
Markham, , Canada
Parkinson's and Neurodegenerative Disorders Clinic
Ottawa, , Canada
Toronto Western Hospital - University Health Network
Toronto, , Canada
Hospital Barros Luco Trudeau
Santiago, , Chile
Hospital Base Valdivia
Valdivia, , Chile
Clinica Ciudad del Mar
Viña del Mar, , Chile
Centro de Investigaciones del Sistema Nervioso Limitada
Bogotá, , Colombia
Fundación Clínica Abood Shaio
Bogotá, , Colombia
Instituto del Corazón
Bucaramanga, , Colombia
Clinical Hospital Osijek
Osijek, , Croatia
Clinical Hospital Center Rijeka
Rijeka, , Croatia
Clinical Hospital "Sestre Milosrdnice"
Zagreb, , Croatia
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
Fakultni nemocnice Brno
Brno, , Czechia
Privatni neurologicka ambulance
Hradec Králové, , Czechia
Poliklinika Modry pavilon
Ostrava, , Czechia
Clintrials.r.o.
Prague, , Czechia
VFN Praha
Prague, , Czechia
Itä-Suomen yliopisto Kuopion kampus
Kuopio, , Finland
Etelä-Karjalan keskussairaala
Lappeenranta, , Finland
ODL Terveys Oy
Oulu, , Finland
Charité Universitaetsmedizin Berlin - Campus Charité Mitte
Berlin, , Germany
Ehret Reinhard
Berlin, , Germany
St. Josef-Hospital
Berlin, , Germany
Eberhard-Karls-Universitaet
Tübingen, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Krishna Institute of Medical Sciences
Hyderabad, , India
Nizam's Institute of Medical Sciences
Hyderabad, , India
Mallikatta Neuro and Research Centre
Mangalore, , India
T.N. Medical College & B.Y.L. Nair Hospital
Mumbai, , India
Brain & Mind Institute
Nagpur, , India
All India Institute of Medical Sciences (AIIMS)
New Delhi, , India
Poona Hospital & Research Center
Pune, , India
Andhra Medical College
Visakhapatnam, , India
AO Universitaria Policlinico di Catania
Catania, , Italy
Fondazione Università Gabriele D'Annunzio
Chieti, , Italy
Ospedale Versilia
Lido di Camaiore, , Italy
Fondazione San Raffaele del Monte Tabor
Milan, , Italy
Istituti Clinici di Perfezionamento
Milan, , Italy
Università degli Studi "Federico II"
Napoli, , Italy
Azienda Ospedaliera Universitaria di Parma
Parma, , Italy
IRCCS S. Raffaele Pisana
Roma, , Italy
Ospedale San Giovanni Battista Ordine di Malta
Roma, , Italy
Policlinico Tor Vergata
Roma, , Italy
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, , Mexico
Instituto Nacional de Neurologia
La Fama, , Mexico
Medical Sur
México, , Mexico
Instituto de Información de Investigación en Salud Mental
Monterrey, , Mexico
Hospital Alberto Sabogal Sologuren
Callao, , Peru
Clinica Anglo Americana
Lima, , Peru
Hospital Nacional Guillermo Almenara Irigoyen
Lima, , Peru
Pomorskie Centr.Traumatologii WSS im.M.Kopernika
Gdansk, , Poland
Hospital de Santa Maria
Lisbon, , Portugal
MU Dr. Beata Dupejova Neurologicka ambulancia s.r.o
Banská Bystrica, , Slovakia
FNsP Bratislava pracovisko Kramare
Bratislava, , Slovakia
Poliklinika Tehelna
Bratislava, , Slovakia
Vseobecna nemocnica s poliklinikou Levoca a.s.
Levoča, , Slovakia
Fakultna nemocnica Trnava
Trnava, , Slovakia
Nestatne zdravotnicke zariadenie
Žilina, , Slovakia
Sandton Clinic
Johannesburg, Gauteng, South Africa
Dr CC Coetzee Inc
Durban, KZ-Natal, South Africa
Constantiaberg Medi-Clinic
Cape Town, , South Africa
Groote Schuur Hospital
Cape Town, , South Africa
St. Augustine's Medical Mews
Durban, , South Africa
Willows Medical Centre
Pretoria, , South Africa
H Clinic i Provincial
Barcelona, , Spain
H de la Santa Creu i Sant Pau
Barcelona, , Spain
H Mutua de Terrassa
Barcelona, , Spain
Policlinica Guipuzcoa
Donostia / San Sebastian, , Spain
Fundacion H. Alcorcon
Madrid, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Countries
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Other Identifiers
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63,901
Identifier Type: -
Identifier Source: secondary_id
EudraCT: 2007-002963-28
Identifier Type: -
Identifier Source: secondary_id
27918
Identifier Type: -
Identifier Source: org_study_id