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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00627640
Other study ID # 27919
Secondary ID IND: 63,901Eudra
Status Completed
Phase Phase 3
First received February 13, 2008
Last updated March 27, 2013
Start date February 2009
Est. completion date March 2012

Study information

Verified date June 2012
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 dopamine-containing 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.

Safinamide is an inhibitor of MAO-B. This is a phase III trial to evaluate the efficacy and safety of safinamide (50 and 100 mg p.o. q.a.m.) compared to placebo as add-on therapy to a stable dose to levodopa in subjects with advance idiopathic Parkinson's Disease.

The principal efficacy measure is the increase in mean daily "on" time during the 18-hr diary recording period.


Recruitment information / eligibility

Status Completed
Enrollment 549
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:

Male and female between the ages of 30 to 80 years with diagnosis of idiopathic Parkinson's Disease of more than 5 years duration, with a Hoehn and Yahr stage of I-IV during an "off" phase.

Be levodopa-responsive and have been receiving treatment with a stable dose of levodopa for at least 4 weeks.

Have motor fluctuations, with >1.5 hours "off" time during the day. Be able to maintain an accurate and complete diary (18-hour)

Exclusion Criteria:

Patients with medical conditions and/or taking concomitant medications that would have put them at risk, interfered with the study evaluations, or made them unable to complete the requirements of the study;.

Be in a late stage of Parkinson's Disease, and experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms.

Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months.

Have received treatment with safinamide previously. History of, or current depression psychosis (e.g. schizophrenia or psychotic depression) Evidence of dementia or cognitive dysfunction. History of allergic response to anticonvulsants, levodopa, or other anti-Parkinsonian agents.

Hypersensitivity or contraindications to MAO-B inhibitors. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Safinimide 50-100 mg/day
Safinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative
Matching Placebo
Matching Placebo

Locations

Country Name City State
Australia Concord Repatriation General Hospital Concord
Australia Central Coast Neuroscience Research East Gosford
Austria Univ.Klinik Graz Graz
Austria Univ.Klinik Innsbruck Innsbruck
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium U.Z Antwerpen Edegem
Belgium Jessa Ziekenhuis - Campus Virga Jesse Hasselt
Belgium ZNA Hoge Beuken Hoboken
Belgium Heilig Hart Roeselare - Campus westlaan Roeselare
Belgium AZ Sint-Augustinus Wilrijk
Canada King David Halifax
Canada Research Site Halifax Nova Scotia
Canada Kingston General Hospital Kingston
Canada Parkinson's and Neurodegenerative Disorders Clinic Ottawa Ontario
Canada Dynamic Clinical Research Group Pointe Claire Quebec
Canada University Health Network -Toronto Western Hosp. Toronto Ontario
Estonia Tartu University Hospital Tartu
France CHU Hopital Gabriel Montpied Clermont Ferrand
France CHU La Miletrie Miletrie Poitiers
France CHU Nantes Hôpital Laennec - CIC Neurologie Nantes Cedex
France CHU de Nimes, Hopital Caremeau Nimes Cedex
France CIC-Hospital Purpan Pavillon Riser Toulouse
Germany Kliniken Beelitz GmbH Beelitz-Heilstaetten
Germany Charité Campus Virchow Universitaetsmedizin Berlin Berlin
Germany Ehret Reinhard Berlin
Germany St. Joseph-Krankenhaus Berlin-Weißensee Berlin
Germany Universitaetsklinikum Goettingen Goettingen
Germany Arzneimittelforschung Leipzig GmbH Leipzig
Germany Philipps-Universitaet Marburg Marburg
Germany Praxis Dipl med Bodenschatz Mittweida
Germany Neurologisches Krankenhaus Muenchen Muenchen
Germany Eberhard-Karls-Universität Tubingen
Germany Universitätsklinikum Ulm
Germany Deutsche Klinik fuer Diagnostik Wiesbaden
Hungary Clinexpert Kereskedelmi es Szolgaltato Kft. Budapest
Hungary Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp. Budapest
Hungary Fovárosi Önkormányzat Nyíro Gyula Kórhaz Neurologiai Osztály Budapest
Hungary Nyiro Gyula Korhaz Budapest
Hungary Semmelweis Egyetem Budapest
Hungary SOTE Neurlogia Budapest
Hungary Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum Debrecen
Hungary Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz Miskolc
Hungary DE OEC Neurologiai Klinika Móricz
Hungary Peterfy S. Utcai Korhaz Peterfy Sandor
Hungary Sopron Medical Egeszsegugyi Szolgaltato Kft. Sopron
Hungary BAZ Country Hospital and Outpatient Clinic Dept. of Neurology Toxicology and Stroke Szentpetri
India M. S. Ramaiah Medical College and Hospital Bangalore Karna
India Nizam's Institute of Medical Sciences Hyderabad Andh Prad
India Mallikatta Neuro and Research Centre Mangalore
India BYL Nair Hospital ¬ TN Medical College Mumbai Mahara
India Brain & Mind Institute Nagpur
India All India Institute of Medical Sciences (AIIMS) New Delhi Delhi
India Christian Medical College Hospital Vellore
India King George Hospital Visakhapatnam Andh Prad
Israel Barzilai Medical Center Ashkelon
Israel Rambam Health Care Campus Haifa
Israel Rabin Medical Center Petach-Tikva
Israel Sheba Medical Center Ramat-Gan
Israel Sourasky Medical Center Tel Aviv
Israel Sieff Government Hospital Zefat
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Severance Hospital, Yonsei University College of Medicine Seoul
Malaysia University of Malaya Medical Center Kuala Lumpur
Malaysia Hospital Pulau Pinang Pinang
Netherlands Jeroen Bosch Ziekenhuis Hertogenbosch
New Zealand Auckland City Hospital Aucklan
New Zealand Van der Veer Institute for Parkinson's & Brain Research Christchurch
New Zealand Waikato Hospital Hamilton
Slovakia MU Dr.Beata Dupejová neurologicka ambulancia s.r.o Banska Bystrica
Slovakia Poliklinika Tehelna Bratislava
Slovakia Vseobecna nemocnica s poliklinikou Levoca Levoca
Slovakia Fakultna nemocnica Trnava Interna klinika Slovak Republic
Slovakia Nestatne zdravotnicke zariadenie Neurologicka ambulancia Slovak Republic
Spain Fundacion Hospital de Alcorcon Madrid
Spain Fundacion Jimenez Diaz Madrid
Spain HU Carlos Haya Malaga
Spain Policlinica Guipuzcoa San Sebastian
Switzerland Inselspital Bern Bern
Switzerland Hopitaux Universitaires de Geneve - Hug Geneve
Taiwan Chang-Hua Christian Hospital Chang Hua
Taiwan Kaohsiung Veterans General Hospital Kaohsiung
Taiwan Shin Kong Wu Ho-Su Memorial Hospital Taipei
Thailand King Chulalongkorn Memorial Hospital Bangkok
Thailand Phramongkutklao Hospital Bangkok
Thailand Rajavithi Hospital Bangkok
Thailand Lampang Hospital Lampang
Thailand Sappasithiprasong Hospital Ubonratchathani
United Kingdom Fylde Coast Hospital Blackpool
United Kingdom Addenbrookes NHS Trust Cambridge
United Kingdom Southern General Hospital Glasgow
United Kingdom Royal Free Hospital London
United Kingdom Clinical Ageing Research Unit Newcastle Upon Tyne
United States Parkinson's Disease and Movement Disorder Center Albany New York
United States Wesley Woods Geriatric Center Atlanta Georgia
United States University of Maryland Medical Center Baltimore Maryland
United States Quest Research Institute Bingham Farms Michigan
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 Rush University Medical Center Chicago Illinois
United States Columbus Research Institute Columbus Georgia
United States Duke Movement Disorders Clinic Durham North Carolina
United States Neurologic Consultants P.A. Fort 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 Vanderbilt University Medical Center Nashville Tennessee
United States Institute for Neurodegenerative Disorders New Haven Connecticut
United States Neurological Institute of New York New York New York
United States Pennsylvania Hospital Philadelphia Pennsylvania
United States Barrow Neurological Institute Phoenix Arizona
United States Parkinson's Disease Treatment Center of SW Florida Port Charlotte Florida
United States San Francisco Clinical Research Center San Francisco California
United States Mayo Clinic Scottsdale Scottsdale Arizona
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

Sponsors (1)

Lead Sponsor Collaborator
Newron

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Estonia,  France,  Germany,  Hungary,  India,  Israel,  Korea, Republic of,  Malaysia,  Netherlands,  New Zealand,  Slovakia,  Spain,  Switzerland,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the change from baseline to W24 in daily "on" time ("on" time without dyskinesia plus "on" time with minor dyskinesia) 24 weeks
Secondary Evaluate the changes from baseline to W24 in Activities of Daily Living, cognition, dyskinesias, change in global clinical status, motor symptoms, motor fluctuations, change in levopoda dose and Health Related Quality of life 24 weeks
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