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Idiopathic Parkinson's DiseasePhase 3MOTIONNCT00605683

MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist

A Phase 3 study testing Safinamide (as add-on therapy) in people with Idiopathic Parkinson's Disease, run by Newron Pharmaceuticals SPA at 125 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Idiopathic Parkinson's Disease
What is being tested?
Safinamide (as add-on therapy)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
679 participants
Where
125 sitesin 20 countries
Study dates
Nov 2007to Mar 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

125 sites in 20 countries.

125 sites in 20 countries

United States31 sites

  • Parkinson's Disease and Movement Disorders Center of Albany

    Albany, New York

  • Emory University

    Atlanta, Georgia

  • Medical College of Georgia

    Augusta, Georgia

  • University of Maryland Medical Center

    Baltimore, Maryland

  • University of Alabama at Birmingham

    Birmingham, Alabama

  • Parkinson's Disease and Movement Disorder Center

    Boca Raton, Florida

  • Boston University School of Medicine

    Boston, Massachusetts

  • The Neurological Institute

    Charlotte, North Carolina

  • Northwestern University PD and Movement Disorders Center

    Chicago, Illinois

  • Cleveland Clinic

    Cleveland, Ohio

  • Columbus Research Institute

    Columbus, Georgia

  • Neurology Specialists

    Dayton, Ohio

  • Duke University Health Systems

    Druham, North Carolina

  • Neurologic Consultants P.A.

    Fort Lauderdale, Florida

  • University Of Florida

    Gainesville, Florida

  • Baylor College of Medicine

    Houston, Texas

  • University of Kansas Medical Center

    Kansas City, Kansas

  • North Shore Medical Center

    Manhasset, New York

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut

  • Columbia University Medical Center

    New York, New York

  • New York University

    New York, New York

  • Pacific Neuroscience Medical Group

    Oxnard, California

  • Arizona Neurological Institute

    Phoenix, Arizona

  • Parkinson's Disease Treatment Center of SW Florida

    Port Charlotte, Florida

  • Oregon Health & Science University

    Portland, Oregon

  • Butler Hospital

    Providence, Rhode Island

  • San Francisco Clinical Research Center

    San Francisco, California

  • Parkinson's Institute

    Sunnyvale, California

  • Neurology Clinical Research Inc.

    Sunrise, Florida

  • University Of South Florida Medical Center

    Tampa, Florida

  • Lankenau Hospital

    Wynnewood, Pennsylvania

Other trials in United States

Argentina11 sites

  • Hospital Español

    Buenos Aires

  • Instituto de Neurociencias Buenos Aires S.A.

    Buenos Aires

  • Clinica IMECO

    Capital Federal

  • Hospital Italiano de Buenos Aires

    Capital Federal

  • Instituto de Investigaciones Neurológicas Raul Carrea FLENI

    Capital Federal

  • Instituto Frenopatico S.A.

    Capital Federal

  • Instituto Argentino de Investigacion Neurologica SRL

    Ciudad Autonoma de

  • Instituto Medico Congreso

    Ciudad Autonoma de Bs. As.

  • Instituto INEBA

    Ciudad Autónoma de Bs. As.

  • Hospital Privado Centro Médico de Córdoba

    Córdoba

  • Hospital Universitario Austral

    Pilar

Other trials in Argentina

Italy10 sites

  • AO Universitaria Policlinico di Catania

    Catania

  • Fondazione Università Gabriele D'Annunzio

    Chieti

  • Ospedale Versilia

    Lido di Camaiore

  • Fondazione San Raffaele del Monte Tabor

    Milan

  • Istituti Clinici di Perfezionamento

    Milan

  • Università degli Studi "Federico II"

    Naples

  • Azienda Ospedaliera Universitaria di Parma

    Parma

  • IRCCS S. Raffaele Pisana

    Roma

  • Ospedale San Giovanni Battista Ordine di Malta

    Roma

  • Policlinico Tor Vergata

    Roma

Other trials in Italy

India8 sites

  • Krishna Institute of Medical Sciences

    Hyderabad

  • Nizam's Institute of Medical Sciences

    Hyderabad

  • Mallikatta Neuro and Research Centre

    Mangalore

  • T.N. Medical College & B.Y.L. Nair Hospital

    Mumbai

  • Brain & Mind Institute

    Nagpur

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi

  • Poona Hospital & Research Center

    Pune

  • Andhra Medical College

    Visakhapatnam

Other trials in India

Bulgaria6 sites

  • CCB Medical Institute - Ministry of Interior

    Sofia

  • First MHAT - Sofia AD

    Sofia

  • MHAT Tokuda Hospital Sofia AD

    Sofia

  • Shatcvd - Nch Ead

    Sofia

  • SHATNP 'Sv. Naum' EAD

    Sofia

  • UMHAT 'Tsaritsa Yoanna - ISUL' EAD

    Sofia

Other trials in Bulgaria

Slovakia6 sites

  • MU Dr. Beata Dupejova Neurologicka ambulancia s.r.o

    Banská Bystrica

  • FNsP Bratislava pracovisko Kramare

    Bratislava

  • Poliklinika Tehelna

    Bratislava

  • Vseobecna nemocnica s poliklinikou Levoca a.s.

    Levoča

  • Fakultna nemocnica Trnava

    Trnava

  • Nestatne zdravotnicke zariadenie

    Žilina

Other trials in Slovakia

South Africa6 sites

  • Constantiaberg Medi-Clinic

    Cape Town

  • Groote Schuur Hospital

    Cape Town

  • Dr CC Coetzee Inc

    Durban, KZ-Natal

  • St. Augustine's Medical Mews

    Durban

  • Sandton Clinic

    Johannesburg, Gauteng

  • Willows Medical Centre

    Pretoria

Other trials in South Africa

Spain6 sites

  • H Clinic i Provincial

    Barcelona

  • H de la Santa Creu i Sant Pau

    Barcelona

  • H Mutua de Terrassa

    Barcelona

  • Policlinica Guipuzcoa

    Donostia / San Sebastian

  • Fundacion H. Alcorcon

    Madrid

  • Fundacion Jimenez Diaz

    Madrid

Other trials in Spain

Canada5 sites

  • Kingston General Hospital

    Kingston

  • Centre For Movement Disorders

    Markham

  • Parkinson's and Neurodegenerative Disorders Clinic

    Ottawa

  • Dynamik Research Inc.

    Pointe-Claire, Quebec, H9R 3J1

  • Toronto Western Hospital - University Health Network

    Toronto

Other trials in Canada

Czechia5 sites

  • Fakultni nemocnice Brno

    Brno

  • Privatni neurologicka ambulance

    Hradec Králové

  • Poliklinika Modry pavilon

    Ostrava

  • Clintrials.r.o.

    Prague

  • VFN Praha

    Prague

Other trials in Czechia

Germany5 sites

  • Charité Universitaetsmedizin Berlin - Campus Charité Mitte

    Berlin

  • Ehret Reinhard

    Berlin

  • St. Josef-Hospital

    Berlin

  • Eberhard-Karls-Universitaet

    Tübingen

  • Universitaetsklinikum Ulm

    Ulm

Other trials in Germany

Brazil4 sites

  • Hospital das Clinicas da UFPR

    Curitiba

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre

  • Centro Pediatrico Professor Hosanna de Oliveira

    Salvador

  • Hospital Universitario Professor Edgard Santos - UFBA

    Salvador

Other trials in Brazil

Croatia4 sites

  • Clinical Hospital Osijek

    Osijek

  • Clinical Hospital Center Rijeka

    Rijeka

  • Clinical Hospital "Sestre Milosrdnice"

    Zagreb

  • Clinical Hospital Centre Zagreb

    Zagreb

Other trials in Croatia

Mexico4 sites

  • Hospital Civil de Guadalajara "Fray Antonio Alcalde"

    Guadalajara

  • Instituto Nacional de Neurologia

    La Fama

  • Medical Sur

    México

  • Instituto de Información de Investigación en Salud Mental

    Monterrey

Other trials in Mexico

Chile3 sites

  • Hospital Barros Luco Trudeau

    Santiago

  • Hospital Base Valdivia

    Valdivia

  • Clinica Ciudad del Mar

    Viña del Mar

Other trials in Chile

Colombia3 sites

  • Centro de Investigaciones del Sistema Nervioso Limitada

    Bogotá

  • Fundación Clínica Abood Shaio

    Bogotá

  • Instituto del Corazón

    Bucaramanga

Other trials in Colombia

Finland3 sites

  • Itä-Suomen yliopisto Kuopion kampus

    Kuopio

  • Etelä-Karjalan keskussairaala

    Lappeenranta

  • ODL Terveys Oy

    Oulu

Other trials in Finland

Peru3 sites

  • Hospital Alberto Sabogal Sologuren

    Callao

  • Clinica Anglo Americana

    Lima

  • Hospital Nacional Guillermo Almenara Irigoyen

    Lima

Other trials in Peru

Poland1 site

  • Pomorskie Centr.Traumatologii WSS im.M.Kopernika

    Gdansk

Other trials in Poland

Portugal1 site

  • Hospital de Santa Maria

    Lisbon

Other trials in Portugal

About this study

Official title: A Phase III, Double-blind, Placebo-controlled Randomised Trial to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist

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.

Being tested
Safinamide (as add-on therapy)
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Safinamide (as add-on therapy)Drug

    Also called Apokyn, Parlodel, Mirapex, Requip

    Safinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative

  • Safinamide (as add-on therapy)Drug

    Also called Apokyn, Parlodel, Mirapex, Requip

    Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist

  • Safinamide (as add-on therapy)Drug

    Also called Apokyn, Parlodel, Mirapex, Requip

    Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist

Study groups in NCT00605683
Study groupRoleWhat they receive
1Active comparator50 mg/day Safinamide
Receives: Drug: Safinamide (as add-on therapy)
2Active comparatorSafinamide 100mg/day
Receives: Drug: Safinamide (as add-on therapy)
3Placebo comparatorPlacebo 0mg/Safinamide
Receives: Drug: Safinamide (as add-on therapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the changes from baseline to W24 in motor symptoms (UPDRS Section III).

    Measured: 24 weeks

Secondary outcomes (1)

  1. 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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2008 (estimated)
  2. Study startNov 2007
  3. Primary completionJan 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
679 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00605683
Sponsor's protocol ID
27918
Other IDs
63,901, EudraCT: 2007-002963-28
Acronym
MOTION
Status last verified
Mar 2013
First submitted
19 Dec 2007
Last updated
29 Oct 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Safinamide (as add-on therapy) in people with Idiopathic Parkinson's Disease, run by Newron Pharmaceuticals SPA at 125 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States, Argentina, Italy, India, Bulgaria and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the changes from baseline to W24 in motor symptoms (UPDRS Section III). (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00605683.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013.

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