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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Newron
ClinicalTrials.gov Identifier:
NCT00627640
First received: February 13, 2008
Last updated: March 27, 2013
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Idiopathic Parkinson's Disease
Drug: Safinimide 50-100 mg/day
Drug: Matching Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Double-blind, Placebo-controlled, Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mg/Day of Safinamide, as add-on Therapy, in Subjects With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, an Anticholinergic and/or Amantadine

Resource links provided by NLM:


Further study details as provided by Newron:

Primary Outcome Measures:
  • Evaluate the change from baseline to W24 in daily "on" time ("on" time without dyskinesia plus "on" time with minor dyskinesia) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 549
Study Start Date: February 2009
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1 active (50 - 100 mg/day)
Drug: Safinimide 50-100 mg/day
Safinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative
Placebo Comparator: 2 Drug: Matching Placebo
Matching Placebo

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627640

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States
United States, Arizona
Barrow Neurological Institute
Phoenix, Arizona, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
United States, California
San Francisco Clinical Research Center
San Francisco, California, United States
Parkinson's Institute
Sunnyvale, California, United States
United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
United States, Florida
Parkinson's Disease and Movement Disorder Center
Boca Raton, Florida, United States
Neurologic Consultants P.A.
Fort Lauderdale, Florida, United States
University of Florida
Gainesville, Florida, United States
Parkinson's Disease Treatment Center of SW Florida
Port Charlotte, Florida, United States
Neurology Clinical Research Inc.
Sunrise, Florida, United States
University Of South Florida Medical Center
Tampa, Florida, United States
United States, Georgia
Wesley Woods Geriatric Center
Atlanta, Georgia, United States
Columbus Research Institute
Columbus, Georgia, United States
United States, Illinois
Northwestern University PD and Movement Disorders Center
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States
United States, Michigan
Quest Research Institute
Bingham Farms, Michigan, United States
United States, New York
Parkinson's Disease and Movement Disorder Center
Albany, New York, United States
North Shore Medical Center
Manhasset, New York, United States
Neurological Institute of New York
New York, New York, United States
United States, North Carolina
The Neurological Institute
Charlotte, North Carolina, United States
Duke Movement Disorders Clinic
Durham, North Carolina, United States
United States, Pennsylvania
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States
United States, Texas
Baylor College of Medicine
Houston, Texas, United States
Australia
Concord Repatriation General Hospital
Concord, Australia
Central Coast Neuroscience Research
East Gosford, Australia
Austria
Univ.Klinik Graz
Graz, Austria
Univ.Klinik Innsbruck
Innsbruck, Austria
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, Belgium
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Parkinson's and Neurodegenerative Disorders Clinic
Ottawa, Ontario, Canada
University Health Network -Toronto Western Hosp.
Toronto, Ontario, Canada
Canada, Quebec
Dynamic Clinical Research Group
Pointe Claire, Quebec, Canada
Canada
King David
Halifax, Canada
Kingston General Hospital
Kingston, Canada
Estonia
Tartu University Hospital
Tartu, Estonia
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, France
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, Germany
Hungary
Clinexpert Kereskedelmi es Szolgaltato Kft.
Budapest, Hungary
Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.
Budapest, Hungary
Fővárosi Önkormányzat Nyírő 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, Hungary
India
Nizam's Institute of Medical Sciences
Hyderabad, Andh Prad, India
King George Hospital
Visakhapatnam, Andh Prad, India
All India Institute of Medical Sciences (AIIMS)
New Delhi, Delhi, 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
Brain & Mind Institute
Nagpur, India
Christian Medical College Hospital
Vellore, India
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, Israel
Korea, Republic of
Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Malaysia
University of Malaya Medical Center
Kuala Lumpur, Malaysia
Hospital Pulau Pinang
Pinang, Malaysia
Netherlands
Jeroen Bosch Ziekenhuis
Hertogenbosch, Netherlands
New Zealand
Auckland City Hospital
Aucklan, New Zealand
Van der Veer Institute for Parkinson's & Brain Research
Christchurch, New Zealand
Waikato Hospital
Hamilton, New Zealand
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, Slovakia
Spain
Fundacion Hospital de Alcorcon
Madrid, Spain
Fundacion Jimenez Diaz
Madrid, Spain
HU Carlos Haya
Malaga, Spain
Policlinica Guipuzcoa
San Sebastian, Spain
Switzerland
Inselspital Bern
Bern, Switzerland
Hopitaux Universitaires de Geneve - Hug
Geneve, Switzerland
Taiwan
Chang-Hua Christian Hospital
Chang Hua, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Thailand
Rajavithi Hospital
Bangkok, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Lampang Hospital
Lampang, Thailand
Sappasithiprasong Hospital
Ubonratchathani, Thailand
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 Kingdom
Sponsors and Collaborators
Newron
Investigators
Study Director: Algirdas Kakarieka, MD Merck Serono S.A., Geneva
  More Information

No publications provided

Responsible Party: Newron
ClinicalTrials.gov Identifier: NCT00627640     History of Changes
Other Study ID Numbers: 27919, IND: 63,901, EudraCT Number: 2007-002964-90
Study First Received: February 13, 2008
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 20, 2014