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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00605683
Other study ID # 27918
Secondary ID 63,901EudraCT: 2
Status Completed
Phase Phase 3
First received December 19, 2007
Last updated October 28, 2013
Start date November 2007
Est. completion date March 2012

Study information

Verified date March 2013
Source Newron
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


Recruitment information / eligibility

Status Completed
Enrollment 679
Est. completion date March 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender All
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

1. 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.

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:

To be eligible for inclusion in this study the subjects must not meet any of the following 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Argentina 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 Argentino de Investigacion Neurologica SRL Ciudad Autonoma de
Argentina Instituto Medico Congreso Ciudad Autonoma de Bs. As.
Argentina Instituto INEBA Ciudad Autónoma de Bs. As.
Argentina Hospital Privado Centro Médico de Córdoba Cordoba
Argentina Hospital Universitario Austral Pilar
Brazil 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
Bulgaria 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
Canada Kingston General Hospital Kingston
Canada Centre For Movement Disorders Markham
Canada Parkinson's and Neurodegenerative Disorders Clinic Ottawa
Canada Dynamik Research Inc. Pointe-Claire Quebec
Canada Toronto Western Hospital - University Health Network Toronto
Chile Hospital Barros Luco Trudeau Santiago
Chile Hospital Base Valdivia Valdivia
Chile Clinica Ciudad del Mar Viña del Mar
Colombia Centro de Investigaciones del Sistema Nervioso Limitada Bogota
Colombia Fundación Clínica Abood Shaio Bogotá
Colombia Instituto del Corazón Bucaramanga
Croatia Clinical Hospital Osijek Osijek
Croatia Clinical Hospital Center Rijeka Rijeka
Croatia Clinical Hospital "Sestre Milosrdnice" Zagreb
Croatia Clinical Hospital Centre Zagreb Zagreb
Czech Republic Fakultni nemocnice Brno Brno
Czech Republic Privatni neurologicka ambulance Hradec Kralove
Czech Republic Poliklinika Modry pavilon Ostrava
Czech Republic Clintrials.r.o. Praha 10
Czech Republic VFN Praha Praha 2
Finland Itä-Suomen yliopisto Kuopion kampus Kuopio
Finland Etelä-Karjalan keskussairaala Lappeenranta
Finland ODL Terveys Oy Oulu
Germany Charité Universitaetsmedizin Berlin - Campus Charité Mitte Berlin
Germany Ehret Reinhard Berlin
Germany St. Josef-Hospital Berlin
Germany Eberhard-Karls-Universitaet Tuebingen
Germany Universitaetsklinikum Ulm Ulm
India 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 Vishakapatnam
Italy 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 Milano
Italy Istituti Clinici di Perfezionamento Milano
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
Mexico Instituto Nacional de Neurologia Colonia La Fama
Mexico Hospital Civil de Guadalajara "Fray Antonio Alcalde" Guadalajara
Mexico Medical Sur Mexico
Mexico Instituto de Información de Investigación en Salud Mental Monterrey
Peru Hospital Alberto Sabogal Sologuren Callao
Peru Clinica Anglo Americana Lima
Peru Hospital Nacional Guillermo Almenara Irigoyen Lima
Poland Pomorskie Centr.Traumatologii WSS im.M.Kopernika Gdansk
Portugal Hospital de Santa Maria Lisboa
Slovakia MU Dr. Beata Dupejova Neurologicka ambulancia s.r.o Banska Bystrica
Slovakia FNsP Bratislava pracovisko Kramare Bratislava
Slovakia Poliklinika Tehelna Bratislava
Slovakia Vseobecna nemocnica s poliklinikou Levoca a.s. Levoca
Slovakia Fakultna nemocnica Trnava Trnava
Slovakia Nestatne zdravotnicke zariadenie Zilina
South Africa Constantiaberg Medi-Clinic Cape Town
South Africa Groote Schuur Hospital Cape Town
South Africa Dr CC Coetzee Inc Durban KZ-Natal
South Africa St. Augustine's Medical Mews Durban
South Africa Sandton Clinic Johannesburg Gauteng
South Africa Willows Medical Centre Pretoria
Spain H Clinic i Provincial Barcelona
Spain H de la Santa Creu i Sant Pau Barcelona
Spain H Mutua de Terrassa Barcelona
Spain Fundacion H. Alcorcon Madrid
Spain Fundacion Jimenez Diaz Madrid
Spain Policlinica Guipuzcoa San Sebastian
United States Parkinson's Disease and Movement Disorders Center of Albany Albany New York
United States Emory University Atlanta Georgia
United States Medical College of Georgia Augusta Georgia
United States University of Maryland Medical Center Baltimore Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States Parkinson's Disease and Movement Disorder Center Boca Raton Florida
United States Boston University School of Medicine Boston Massachusetts
United States The Neurological Institute Charlotte North Carolina
United States Northwestern University PD and Movement Disorders Center Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States Columbus Research Institute Columbus Georgia
United States Neurology Specialists Dayton Ohio
United States Duke University Health Systems Druham North Carolina
United States Neurologic Consultants P.A. Ft Lauderdale Florida
United States University Of Florida Gainesville Florida
United States Baylor College of Medicine Houston Texas
United States University of Kansas Medical Center Kansas City Kansas
United States North Shore Medical Center Manhasset New York
United States Institute for Neurodegenerative Disorders New Haven Connecticut
United States Columbia University Medical Center New York New York
United States New York University New York New York
United States Pacific Neuroscience Medical Group Oxnard California
United States Arizona Neurological Institute Phoenix Arizona
United States Parkinson's Disease Treatment Center of SW Florida Port Charlotte Florida
United States Oregon Health & Science University Portland Oregon
United States Butler Hospital Providence Rhode Island
United States San Francisco Clinical Research Center San Francisco California
United States Parkinson's Institute Sunnyvale California
United States Neurology Clinical Research Inc. Sunrise Florida
United States University Of South Florida Medical Center Tampa Florida
United States Lankenau Hospital Wynnewood Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Newron

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Croatia,  Czech Republic,  Finland,  Germany,  India,  Italy,  Mexico,  Peru,  Poland,  Portugal,  Slovakia,  South Africa,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the changes from baseline to W24 in motor symptoms (UPDRS Section III). 24 weeks
Secondary 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
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