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

About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease
Eligibility Criteria
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.
Sites / Locations
- University of Alabama at Birmingham
- Barrow Neurological Institute
- Mayo Clinic Scottsdale
- San Francisco Clinical Research Center
- Parkinson's Institute
- Institute for Neurodegenerative Disorders
- Parkinson's Disease and Movement Disorder Center
- Neurologic Consultants P.A.
- University of Florida
- Parkinson's Disease Treatment Center of SW Florida
- Neurology Clinical Research Inc.
- University Of South Florida Medical Center
- Wesley Woods Geriatric Center
- Columbus Research Institute
- Northwestern University PD and Movement Disorders Center
- Rush University Medical Center
- University of Kansas Medical Center
- University of Maryland Medical Center
- Boston University School of Medicine
- Quest Research Institute
- Parkinson's Disease and Movement Disorder Center
- North Shore Medical Center
- Neurological Institute of New York
- The Neurological Institute
- Duke Movement Disorders Clinic
- Pennsylvania Hospital
- Vanderbilt University Medical Center
- Baylor College of Medicine
- Concord Repatriation General Hospital
- Central Coast Neuroscience Research
- Univ.Klinik Graz
- Univ.Klinik Innsbruck
- Cliniques Universitaires Saint-Luc
- U.Z Antwerpen
- Jessa Ziekenhuis - Campus Virga Jesse
- ZNA Hoge Beuken
- Heilig Hart Roeselare - Campus westlaan
- AZ Sint-Augustinus
- Research Site
- Parkinson's and Neurodegenerative Disorders Clinic
- University Health Network -Toronto Western Hosp.
- Dynamic Clinical Research Group
- King David
- Kingston General Hospital
- Tartu University Hospital
- CHU Hopital Gabriel Montpied
- CHU La Miletrie
- CHU Nantes Hôpital Laennec - CIC Neurologie
- CHU de Nimes, Hopital Caremeau
- CIC-Hospital Purpan
- Kliniken Beelitz GmbH
- Charité Campus Virchow Universitaetsmedizin Berlin
- Ehret Reinhard
- St. Joseph-Krankenhaus Berlin-Weißensee
- Universitaetsklinikum Goettingen
- Arzneimittelforschung Leipzig GmbH
- Philipps-Universitaet Marburg
- Praxis Dipl med Bodenschatz
- Neurologisches Krankenhaus Muenchen
- Eberhard-Karls-Universität
- Universitätsklinikum
- Deutsche Klinik fuer Diagnostik
- Clinexpert Kereskedelmi es Szolgaltato Kft.
- Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.
- Fővárosi Önkormányzat Nyírő Gyula Kórhaz Neurologiai Osztály
- Nyiro Gyula Korhaz
- Semmelweis Egyetem
- SOTE Neurlogia
- Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
- Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
- DE OEC Neurologiai Klinika
- Peterfy S. Utcai Korhaz
- Sopron Medical Egeszsegugyi Szolgaltato Kft.
- BAZ Country Hospital and Outpatient Clinic Dept. of Neurology Toxicology and Stroke
- Nizam's Institute of Medical Sciences
- King George Hospital
- All India Institute of Medical Sciences (AIIMS)
- M. S. Ramaiah Medical College and Hospital
- Mallikatta Neuro and Research Centre
- BYL Nair Hospital ¬ TN Medical College
- Brain & Mind Institute
- Christian Medical College Hospital
- Barzilai Medical Center
- Rambam Health Care Campus
- Rabin Medical Center
- Sheba Medical Center
- Sourasky Medical Center
- Sieff Government Hospital
- Asan Medical Center
- Samsung Medical Center
- Severance Hospital, Yonsei University College of Medicine
- University of Malaya Medical Center
- Hospital Pulau Pinang
- Jeroen Bosch Ziekenhuis
- Auckland City Hospital
- Van der Veer Institute for Parkinson's & Brain Research
- Waikato Hospital
- MU Dr.Beata Dupejová neurologicka ambulancia s.r.o
- Poliklinika Tehelna
- Vseobecna nemocnica s poliklinikou Levoca
- Fakultna nemocnica Trnava Interna klinika
- Nestatne zdravotnicke zariadenie Neurologicka ambulancia
- Fundacion Hospital de Alcorcon
- Fundacion Jimenez Diaz
- HU Carlos Haya
- Policlinica Guipuzcoa
- Inselspital Bern
- Hopitaux Universitaires de Geneve - Hug
- Chang-Hua Christian Hospital
- Kaohsiung Veterans General Hospital
- Shin Kong Wu Ho-Su Memorial Hospital
- King Chulalongkorn Memorial Hospital
- Phramongkutklao Hospital
- Rajavithi Hospital
- Lampang Hospital
- Sappasithiprasong Hospital
- Fylde Coast Hospital
- Addenbrookes NHS Trust
- Southern General Hospital
- Royal Free Hospital
- Clinical Ageing Research Unit
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
1 active (50 - 100 mg/day)