Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa

Phase 3

Completed

• Conditions: Idiopathic Parkinson's Disease
• Interventions: Drug: Safinimide 50-100 mg/day; Drug: Matching Placebo

• Registration Number: NCT00627640
• Lead Sponsor: Newron Pharmaceuticals SPA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-29
• Study First Posted: 2008-03-03
• Study Start: 2009-02
• Primary Completion: 2012-01
• Study Completion: 2012-03
• Status Verified: 2012-06
• Last Update Submitted: 2013-03-27
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 549

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Safinimide 50-100 mg/day	1 active (50 - 100 mg/day)
2	Matching Placebo	-

Primary Outcome Measures

Name	Time	Method
Evaluate the change from baseline to W24 in daily "on" time ("on" time without dyskinesia plus "on" time with minor dyskinesia)	24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (120)

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; 🇭🇺 Miskolc, Hungary

SOTE Neurlogia; 🇭🇺 Budapest, Hungary

Nizam's Institute of Medical Sciences; 🇮🇳 Hyderabad, Andh Prad, India

Peterfy S. Utcai Korhaz; 🇭🇺 Peterfy Sandor, Hungary

Parkinson's Disease and Movement Disorder Center; 🇺🇸 Albany, New York, United States

Parkinson's Disease Treatment Center of SW Florida; 🇺🇸 Port Charlotte, Florida, United States

Wesley Woods Geriatric Center; 🇺🇸 Atlanta, Georgia, United States

Northwestern University PD and Movement Disorders Center; 🇺🇸 Chicago, Illinois, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

North Shore Medical Center; 🇺🇸 Manhasset, New York, United States

University Health Network -Toronto Western Hosp.; 🇨🇦 Toronto, Ontario, Canada

Boston University School of Medicine; 🇺🇸 Boston, Massachusetts, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Rabin Medical Center; 🇮🇱 Petach-Tikva, Israel

Sheba Medical Center; 🇮🇱 Ramat-Gan, Israel

Hospital Pulau Pinang; 🇲🇾 Pinang, Malaysia

Jeroen Bosch Ziekenhuis; 🇳🇱 Hertogenbosch, Netherlands

CHU Nantes Hôpital Laennec - CIC Neurologie; 🇫🇷 Nantes Cedex, France

Van der Veer Institute for Parkinson's & Brain Research; 🇳🇿 Christchurch, New Zealand

Rambam Health Care Campus; 🇮🇱 Haifa, Israel

University of Malaya Medical Center; 🇲🇾 Kuala Lumpur, Malaysia

MU Dr.Beata Dupejová neurologicka ambulancia s.r.o; 🇸🇰 Banska Bystrica, Slovakia

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Brain & Mind Institute; 🇮🇳 Nagpur, India

Sieff Government Hospital; 🇮🇱 Zefat, Israel

Christian Medical College Hospital; 🇮🇳 Vellore, India

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of

Barzilai Medical Center; 🇮🇱 Ashkelon, Israel

All India Institute of Medical Sciences (AIIMS); 🇮🇳 New Delhi, Delhi, India

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, 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

University Of South Florida Medical Center; 🇺🇸 Tampa, Florida, United States

Neurology Clinical Research Inc.; 🇺🇸 Sunrise, Florida, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Neurologic Consultants P.A.; 🇺🇸 Fort Lauderdale, Florida, United States

Columbus Research Institute; 🇺🇸 Columbus, Georgia, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Quest Research Institute; 🇺🇸 Bingham Farms, Michigan, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

The Neurological Institute; 🇺🇸 Charlotte, North Carolina, United States

Duke Movement Disorders Clinic; 🇺🇸 Durham, North Carolina, United States

Neurological Institute of New York; 🇺🇸 New York, New York, United States

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Central Coast Neuroscience Research; 🇦🇺 East Gosford, Australia

Concord Repatriation General Hospital; 🇦🇺 Concord, Australia

Univ.Klinik Graz; 🇦🇹 Graz, Austria

Jessa Ziekenhuis - Campus Virga Jesse; 🇧🇪 Hasselt, Belgium

Univ.Klinik Innsbruck; 🇦🇹 Innsbruck, Austria

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

U.Z Antwerpen; 🇧🇪 Edegem, Belgium

ZNA Hoge Beuken; 🇧🇪 Hoboken, Belgium

Heilig Hart Roeselare - Campus westlaan; 🇧🇪 Roeselare, Belgium

AZ Sint-Augustinus; 🇧🇪 Wilrijk, Belgium

Parkinson's and Neurodegenerative Disorders Clinic; 🇨🇦 Ottawa, Ontario, Canada

Research Site; 🇨🇦 Halifax, Nova Scotia, Canada

Dynamic Clinical Research Group; 🇨🇦 Pointe Claire, Quebec, Canada

Tartu University Hospital; 🇪🇪 Tartu, Estonia

King David; 🇨🇦 Halifax, Canada

Kingston General Hospital; 🇨🇦 Kingston, Canada

CHU Hopital Gabriel Montpied; 🇫🇷 Clermont Ferrand, France

CHU La Miletrie; 🇫🇷 Miletrie Poitiers, France

CHU de Nimes, Hopital Caremeau; 🇫🇷 Nimes Cedex, France

CIC-Hospital Purpan; 🇫🇷 Pavillon Riser Toulouse, France

Ehret Reinhard; 🇩🇪 Berlin, Germany

Charité Campus Virchow Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany

Kliniken Beelitz GmbH; 🇩🇪 Beelitz-Heilstaetten, Germany

St. Joseph-Krankenhaus Berlin-Weißensee; 🇩🇪 Berlin, Germany

Universitaetsklinikum Goettingen; 🇩🇪 Goettingen, Germany

Philipps-Universitaet Marburg; 🇩🇪 Marburg, Germany

Arzneimittelforschung Leipzig GmbH; 🇩🇪 Leipzig, Germany

Praxis Dipl med Bodenschatz; 🇩🇪 Mittweida, Germany

Deutsche Klinik fuer Diagnostik; 🇩🇪 Wiesbaden, Germany

Neurologisches Krankenhaus Muenchen; 🇩🇪 Muenchen, Germany

Eberhard-Karls-Universität; 🇩🇪 Tubingen, Germany

Universitätsklinikum; 🇩🇪 Ulm, Germany

Clinexpert Kereskedelmi es Szolgaltato Kft.; 🇭🇺 Budapest, Hungary

Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.; 🇭🇺 Budapest, Hungary

Semmelweis Egyetem; 🇭🇺 Budapest, Hungary

Fővárosi Önkormányzat Nyírő Gyula Kórhaz Neurologiai Osztály; 🇭🇺 Budapest, Hungary

Nyiro Gyula Korhaz; 🇭🇺 Budapest, Hungary

DE OEC Neurologiai Klinika; 🇭🇺 Móricz, Hungary

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum; 🇭🇺 Debrecen, Hungary

Sopron Medical Egeszsegugyi Szolgaltato Kft.; 🇭🇺 Sopron, Hungary

BAZ Country Hospital and Outpatient Clinic Dept. of Neurology Toxicology and Stroke; 🇭🇺 Szentpetri, Hungary

King George Hospital; 🇮🇳 Visakhapatnam, Andh Prad, India

M. S. Ramaiah Medical College and Hospital; 🇮🇳 Bangalore, Karna, India

Mallikatta Neuro and Research Centre; 🇮🇳 Mangalore, India

BYL Nair Hospital ¬ TN Medical College; 🇮🇳 Mumbai Mahara, India

Auckland City Hospital; 🇳🇿 Aucklan, New Zealand

Waikato Hospital; 🇳🇿 Hamilton, New Zealand

Vseobecna nemocnica s poliklinikou Levoca; 🇸🇰 Levoca, Slovakia

Poliklinika Tehelna; 🇸🇰 Bratislava, Slovakia

Fakultna nemocnica Trnava Interna klinika; 🇸🇰 Slovak Republic, Slovakia

Nestatne zdravotnicke zariadenie Neurologicka ambulancia; 🇸🇰 Slovak Republic, Slovakia

Inselspital Bern; 🇨🇭 Bern, Switzerland

HU Carlos Haya; 🇪🇸 Malaga, Spain

Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

Fundacion Hospital de Alcorcon; 🇪🇸 Madrid, Spain

Chang-Hua Christian Hospital; 🇨🇳 Chang Hua, Taiwan

Hopitaux Universitaires de Geneve - Hug; 🇨🇭 Geneve, Switzerland

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan

Policlinica Guipuzcoa; 🇪🇸 San Sebastian, Spain

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand

Phramongkutklao Hospital; 🇹🇭 Bangkok, Thailand

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

Lampang Hospital; 🇹🇭 Lampang, Thailand

Sappasithiprasong Hospital; 🇹🇭 Ubonratchathani, Thailand

Clinical Ageing Research Unit; 🇬🇧 Newcastle Upon Tyne, United Kingdom

Fylde Coast Hospital; 🇬🇧 Blackpool, United Kingdom

Addenbrookes NHS Trust; 🇬🇧 Cambridge, United Kingdom

Royal Free Hospital; 🇬🇧 London, United Kingdom

Southern General Hospital; 🇬🇧 Glasgow, United Kingdom

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States