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

March 27, 2013 updated by: Newron Pharmaceuticals SPA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

549

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Matching Placebo
Matching Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newron Pharmaceuticals SPA

Investigators

  • Study Director: Algirdas Kakarieka, MD, Merck Serono S.A., Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (Estimate)

March 3, 2008

Study Record Updates

Last Update Posted (Estimate)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27919
  • IND: 63,901
  • EudraCT Number: 2007-002964-90

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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